Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate (NCT02665117), a randomized na study. The primary outcome is Change in Fasting Plasma Glucose From Week 4 to Week 16.

2. Clinical Question

The trial addresses the possibility that metabolic changes during chlorthalidone treatment might differ according to the supplement used. The registry summary describes a rationale involving several potential metabolic effects and says the study aimed to assess effects independent of correction of hypokalemia. The posted primary endpoint, however, is fasting plasma glucose change. The registry record does not report an endpoint measuring insulin resistance or metabolic syndrome, nor does it report a separate result establishing that any observed glucose difference is independent of potassium correction.

The registry lists hypertension as the condition and describes randomization after a chlorthalidone run-in. It does not report detailed eligibility criteria, participant characteristics, or how representative the enrolled group was of people treated outside the trial. The clinical question should therefore be read narrowly: it is an add-on comparison in the context of chlorthalidone use, using the glucose change measured over the specified follow-up interval.

3. Trial Design

The registry describes a randomized, double-blind, parallel-group trial. Participants completed a chlorthalidone run-in period of 2-3 weeks and were then assigned to KMgCitrate plus chlorthalidone or potassium chloride plus chlorthalidone. The assigned supplement was used for 4 months. The trial is listed as completed, with enrollment of 61 and a primary completion date of 2022-11-04. The phase is listed as NA.

The primary endpoint was change in fasting plasma glucose from week 4 to week 16, measured from venous blood samples. The arm summaries report 29 participants for KMgCitrate plus chlorthalidone and 31 for potassium chloride plus chlorthalidone. These are the outcome counts attached to the posted primary results; the registry record does not describe the analysis population or explain the relationship between those counts and enrollment.

Three secondary outcomes are posted: change in hepatic fat from baseline to week 16, change in muscle magnesium content from baseline to week 16, and change in FGF23 from week 4 to week 16. The arm counts for the hepatic fat and muscle magnesium outcomes are 19 in each group; for FGF23 they are 29 and 31. The registry does not report why the available counts differ across outcomes.

The record identifies the University of Texas Southwestern Medical Center as sponsor. It does not report the randomization sequence method, allocation concealment method, precise masking procedures, or details of adherence and treatment discontinuation. It also does not report the original design assumptions or a sample-size justification. These omissions limit what can be concluded about trial conduct from the registry record alone.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change in Fasting Plasma Glucose From Week 4 to Week 16, measured over week 4 and week 16.

The primary endpoint is change in fasting plasma glucose from week 4 to week 16, expressed in mg/dL. Fasting plasma glucose is a continuous laboratory measure. In this trial, measuring change over time provides a way to describe whether the group averages moved upward or downward during the follow-up interval, and comparing the average changes addresses whether those movements differed between the two assigned supplement groups.

The week 4 measurement is the starting point for the posted primary change, rather than the beginning of the chlorthalidone run-in. The registry says that fasting glucose was measured from venous blood at week 4 and week 16. Consequently, the primary result should be interpreted as a between-group comparison of change during that interval while participants were receiving their assigned supplement with chlorthalidone. It is not a comparison of glucose levels before any chlorthalidone exposure, and the posted result does not isolate the effect of chlorthalidone itself.

Continuous outcomes are commonly summarized by a mean and a measure of spread. Here, the arm results use means and standard deviations. The mean describes the average observed change within an arm, while the standard deviation describes how variable individual observations were around that arm average. Neither summary gives the full distribution of participant outcomes. The registry record does not report a clinically important threshold for glucose change, so the statistical contrast alone does not establish whether its magnitude is clinically meaningful.

7. Results Posted in the Registry

• KCl + Chlorthalidone: mean 2.30 versus -5.60 on control; difference 7.90 (95% CI 1.94 to 13.86), standardized effect d = 0.68; z-test p = 0.009.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Chang in Hepatic Fat Measured at Baseline and Week 16

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • KCl + Chlorthalidone: mean 1.59 versus 0.31 on control; difference 1.28 (95% CI -1.24 to 3.80), standardized effect d = 0.32; z-test p = 0.320.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between KCl + Chlorthalidone and the control. The interval gives the range of effects that remain compatible with the data.

Change in Muscle Magnesium Content Measured at Baseline and Week 16

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • KCl + Chlorthalidone: mean 0.02 versus -0.01 on control; difference 0.03 (95% CI -0.03 to 0.09), standardized effect d = 0.33; z-test p = 0.307.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between KCl + Chlorthalidone and the control. The interval gives the range of effects that remain compatible with the data.

Change in FGF23 From Week 4 to Week 16

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • KCl + Chlorthalidone: mean 13.60 versus 38.10 on control; difference -24.50 (95% CI -82.44 to 33.44), standardized effect d = -0.22; z-test p = 0.407.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between KCl + Chlorthalidone and the control. The interval gives the range of effects that remain compatible with the data.

The secondary endpoints broaden the assessment beyond fasting plasma glucose, covering hepatic fat, muscle magnesium content, and FGF23. Taken together, their posted estimates do not form a clear, consistent pattern that independently reinforces the primary glucose comparison. The directions and precision vary across measures, and the reported intervals for these secondary comparisons include values on both sides of zero.

These outcomes relate to the primary result as additional metabolic measurements within the same comparison of supplement strategies. They can help describe whether the observed primary pattern is accompanied by differences in other measured features, but they do not explain the mechanism behind a glucose difference. The registry does not report analyses testing mediation or a causal pathway linking the secondary outcomes to glucose. Nor does it report a secondary endpoint measuring insulin resistance or metabolic syndrome.

Unadjusted secondary results generally carry less weight when multiple outcomes are examined. Each additional test creates another opportunity for a seemingly notable result to arise by chance. A prespecified hierarchy, multiplicity adjustment, or clear designation of exploratory outcomes can guide interpretation, but those details are not reported in the registry record. No secondary analysis records are posted. This does not show that no analyses were performed; it means the registry does not report them as analysis records.

The available counts for hepatic fat and muscle magnesium are lower than those for the primary endpoint, and the record does not explain the difference. This limits confidence in comparisons across outcomes and makes it especially important not to read the secondary summaries as a unified test of the trial's overall biological rationale. They are descriptive and exploratory in the absence of further analysis details, and they should not override the primary endpoint or be presented as definitive evidence for or against a treatment effect.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Chang in Hepatic Fat Measured at Baseline and Week 16
• Change in Muscle Magnesium Content Measured at Baseline and Week 16
• Change in FGF23 From Week 4 to Week 16

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, so the registry summarizes each arm with a mean change and standard deviation, then reports a difference between arm means. The comparison is oriented as potassium chloride plus chlorthalidone minus KMgCitrate plus chlorthalidone. A positive difference therefore means the average change was higher in the potassium chloride arm. Reading the direction of a contrast depends on this ordering, not just on whether the estimate is positive or negative.

What does a mean difference represent?

A mean difference compares the average outcome change in one group with the average change in another. It preserves the outcome's original units, which in the primary endpoint are mg/dL. It is not the same as either arm's mean change considered alone. The two arm means describe the observed average movement within each assigned group; the between-group estimate describes how far apart those average movements were.

The standard deviation is a description of spread among observations in an arm. It is not the standard error of the mean and is not a confidence interval. Standard errors quantify uncertainty in an estimate and are influenced by both outcome variability and the number of observations contributing to the estimate. The registry reports arm standard deviations as well as standard errors in the comparison summaries, but does not describe the calculation methods in detail.

How should the confidence interval be read?

A confidence interval expresses uncertainty about an estimated difference using a range of values compatible with the data and the method used to construct the interval. It is not a range containing a specified proportion of individual participant outcomes. A narrower interval generally indicates greater precision; a wider interval indicates that the estimate is less precise. The primary interval, 1.935 to 13.86 mg/dL, lies on the positive side of zero. The intervals for the secondary comparisons extend across zero, leaving more uncertainty about the direction of those contrasts.

The p-value is a measure of how incompatible the observed data are with a specified null hypothesis under the statistical model used. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of a difference. The primary p-value is reported as unadjusted. The registry does not report whether other adjustments or model-based analyses were part of the study's own analysis plan.

Why does outcome variability matter?

When observations vary substantially within groups, it can be harder to estimate the difference between group averages precisely. In clinical data, variability may reflect real differences among participants, measurement variation, or other sources. If a continuous outcome has a distribution with more extreme values or greater spread than a simple model assumes, over-dispersion can make standard errors too small and confidence intervals too narrow if it is not handled appropriately. This is a general statistical consideration, not a claim that over-dispersion occurred in this trial. The registry does not report distributional diagnostics or an alternative variance model.

Means and standard deviations provide a compact description but do not reveal skewness, outliers, or subgroup patterns. The record does not post individual participant data or plots of outcome distributions. Therefore, the summaries alone cannot establish whether the mean adequately captures the shape of the observed data or whether particular observations had strong influence on the estimate.

What does randomization contribute?

Random assignment is intended to make the groups comparable, on average, with respect to factors that might affect the outcome. It supports interpretation of a between-group difference as a treatment-assignment contrast, provided the trial was conducted and analyzed appropriately. Randomization does not guarantee that every measured or unmeasured characteristic is balanced, particularly in a trial with limited numbers of observations. The registry identifies the trial as randomized but does not report the sequence-generation or concealment procedures, baseline characteristics, or adjusted analyses needed to assess those features further.

Double masking is also listed, but the registry does not specify who was masked or how masking was maintained. Masking can reduce the risk that knowledge of assignment changes care, measurement, or reporting; its actual protection depends on implementation. The designation alone does not establish how successfully masking worked.

What is the role of the posted recalculations?

The comparison summaries present unadjusted comparisons based on the arm-level statistics. Such calculations describe the contrast implied by the posted means and variation, but they do not replace an analysis conducted under the trial's prespecified plan. The registry's discrepancy indicator is false, so the posted comparison is not flagged as conflicting with a sponsor analysis in the record. The registry does not report a separate sponsor analysis for the secondary outcomes. The appropriate interpretation remains bounded by what is documented: the outcome summaries and comparisons are available, while the full statistical plan and analysis details are not reported.

General statistical methods can help explain the estimates, but they cannot fill gaps in the record. In particular, they cannot establish how missing measurements, protocol deviations, multiple endpoints, or baseline differences were handled. Those details matter for judging how robustly the posted estimates represent the randomized comparison.

11. Confidence Intervals and Precision

Precision is about how tightly the data locate an estimated effect, not whether the result is important. The primary mean-difference estimate is 7.9 mg/dL, with a 95% confidence interval from 1.935 to 13.86 mg/dL. The interval spans a range of plausible differences on the positive side of zero. It therefore conveys both the direction supported by the reported interval and uncertainty about the magnitude. The endpoints should not be read as exact bounds on the true effect.

The interval is more informative than the p-value alone because it gives a range and retains the measurement scale. The p-value of 0.009 indicates evidence against a zero difference under the unadjusted comparison, while the interval communicates how precise the estimated difference is. Neither statistic resolves whether the difference is clinically important; the registry does not report a threshold for that judgment.

For the secondary comparisons, the reported intervals cross zero. That means the data are compatible, under the interval method, with differences in either direction. This does not prove there is no difference. Rather, the available estimates do not identify a single direction with comparable clarity to the primary comparison. The record also does not report multiplicity-adjusted intervals.

Precision depends on both the amount of outcome variation and the number of observations contributing to the estimate. The primary arm counts are 29 and 31, while the hepatic fat and muscle magnesium outcomes each have arm counts of 19. Those counts and the reported variability help contextualize why estimates can be uncertain, but the registry does not explain differences in outcome availability or provide details on missing-data handling. The reported intervals should therefore be interpreted alongside those limitations, not as a complete account of uncertainty from trial conduct or analysis choices.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for a two-arm comparison. They are not total event counts: the outcomes are continuous, and the planning illustration concerns participants per arm. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. The target effect is set at the stated fraction of the observed effect. The trial's original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the specified effect if that effect is present and the planning assumptions hold. The 90% column gives the corresponding number for a higher chance of detecting that effect. These are planning quantities, not promises about what a future study will achieve. They depend on the assumed effect and variability, as well as on the stated testing and allocation assumptions.

Rows that plan for 75% or 50% of the observed effect assume a smaller difference to detect than the row based on 100% of the observed effect. Smaller effects generally require more participants to distinguish them from random variation with the same power target. The table and curve should be read as illustrations of how the required group size changes under those specified assumptions, rather than as evidence that the trial had a particular probability of finding its result.

This is not observed power. It is a forward-looking planning illustration derived from the observed effect, not a measure of how successful the completed trial was at detecting an effect. Because observed effects can be uncertain, especially in limited samples, the planning estimates should not be treated as a definitive basis for a new study without an independently justified effect and design.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 7.900; pooled standard deviation σ = 11.666.
2. n = 2 × (1.96 + 0.842)² × 11.666² / 7.900² = 34.2, rounded up to 35 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 7.9                      # observed difference in means
sigma <- 11.6657618696766                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2665117)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 35 (80% power), 46 (90% power)
 75% of observed effect: n per arm = 61 (80% power), 82 (90% power)
 50% of observed effect: n per arm = 137 (80% power), 184 (90% power)
power.t.test: 35.2 
Simulated power at n = 35 per arm: 0.796 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary endpoint and three secondary endpoints, but it does not report how the analysis plan handled multiple outcomes. No multiplicity procedure, testing hierarchy, or adjusted result is recorded. Because repeated testing across endpoints can increase the chance of a false-positive finding, the unadjusted secondary comparisons should be interpreted cautiously. The primary comparison is also reported with an unadjusted p-value; the registry does not state whether other planned tests were considered when interpreting that result.

The record shows no reported analysis records for the secondary outcomes. This is a limitation in the available documentation, not evidence that no statistical analyses were conducted. The original statistical analysis plan, including any prespecified models, covariates, subgroup analyses, or sensitivity analyses, is not reported in the registry record. Interim analyses are also not reported.

Missing-data methods and the analysis population are not reported. The outcome counts differ across measures: the primary and FGF23 summaries list 29 and 31 participants in the respective arms, while the hepatic fat and muscle magnesium summaries list 19 in each arm. Those figures identify the observations represented in the outcome summaries, but they do not explain why fewer observations contribute to some outcomes. The registry does not state whether missing values were imputed, whether analyses used complete cases, or how withdrawals and protocol deviations were handled.

These omissions affect interpretation because different analysis choices can change estimates and uncertainty. Without a stated analysis population and missing-data approach, it is not possible to determine from the registry whether the reported comparisons include all randomized participants or a subset defined by outcome availability or another rule. The record also does not provide enough information to assess whether the analysis followed a prespecified plan. Conclusions should remain limited to the posted arm summaries and comparisons.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports zero serious adverse events and zero deaths in both groups. For other adverse events, it reports 2 affected participants in the KMgCitrate plus chlorthalidone group and 0 in the potassium chloride plus chlorthalidone group. The at-risk counts recorded for these categories are 29 and 31, respectively. No serious adverse-event terms are listed.

These counts describe what is recorded in the registry; they do not establish that no unrecorded events occurred. The record does not provide event descriptions for the other adverse events, their severity, timing, relationship to study treatment, or whether any participant experienced more than one event. It also does not describe how adverse events were collected or assessed. A zero count for serious events in a group is not proof that the risk is absent, particularly when the available safety observations are limited.

The figures should be read as descriptive safety reporting for the trial, not as a comprehensive comparison of safety between treatment strategies. They do not establish that one supplement is safer, and they do not support conclusions about uncommon or delayed events.

16. What the Result Does, and Does Not, Mean

The result supports a limited statistical statement: the posted mean change in fasting plasma glucose from week 4 to week 16 differed between the two randomized groups. The estimated contrast is positive when expressed as potassium chloride minus KMgCitrate, and the reported confidence interval is on the positive side of zero. The arm averages show a decrease in the KMgCitrate group and an increase in the potassium chloride group over that interval.

This is not a comparison of chlorthalidone with no chlorthalidone. Both groups received chlorthalidone, and the randomized contrast was the addition of KMgCitrate versus potassium chloride. The result does not establish the effect of either supplement compared with no supplement, or the effect of chlorthalidone compared with another blood-pressure treatment.

The result also does not establish a mechanism. The study summary describes a rationale involving multiple possible metabolic effects, but the registry results do not show that the glucose contrast arose through any particular pathway or that it was independent of correction of hypokalemia. The posted secondary endpoints do not provide a definitive explanation for the primary result.

Statistical evidence of a difference does not by itself indicate clinical importance. The registry does not report a threshold for a meaningful glucose change, broader clinical outcomes, or follow-up beyond the stated measurement interval. The result cannot establish whether the observed difference persists, affects later health outcomes, or applies to people outside the trial's enrolled population.

Finally, interpretation is constrained by the absence of reported details on missing data, analysis populations, the original statistical plan, and multiplicity. Those gaps do not erase the posted estimates, but they limit how fully their reliability and scope can be assessed. The record supports describing the observed comparison and its uncertainty, not making a broader claim that a treatment does or does not work.

17. Why This Trial Matters Statistically

This trial is statistically informative because it compares two active supplement strategies in a shared chlorthalidone context. That design makes the primary contrast specific: it addresses the difference between adding KMgCitrate and adding potassium chloride after a chlorthalidone run-in. It does not answer every question raised by the broader metabolic rationale, but it provides a direct randomized comparison for the posted glucose endpoint.

The primary result also illustrates why an estimate, an interval, and a p-value answer different questions. The mean difference expresses the contrast in the outcome's units; the confidence interval communicates uncertainty about its size; and the unadjusted p-value describes compatibility with a zero-difference hypothesis under the method used. None substitutes for a clinical threshold or for a complete assessment of trial conduct.

The trial also highlights the importance of outcome availability and transparent analysis reporting. The posted counts vary across endpoints, while the registry does not explain missing observations or identify the analysis population. A reader can describe the summaries, but cannot determine from the record alone how all randomized participants were handled or whether the planned analysis matches the posted comparison.

Finally, the secondary endpoints show why a mechanistic rationale should not be treated as a result. Additional measures can help characterize a trial, but unadjusted comparisons across multiple outcomes require caution, especially when the analysis plan and multiplicity approach are not reported. The statistical value of the record lies in the specific comparison and estimates it documents, alongside a clear recognition of what remains uncertain.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations are specific to the available record for this trial. Both groups received chlorthalidone, so the comparison cannot separate the effects of chlorthalidone from the effects of the supplements or establish how either supplement compares with no added supplement. The primary endpoint begins at week 4, after the reported run-in period, and concerns change through week 16; it does not describe glucose change from before chlorthalidone treatment.

The primary arm counts are 29 and 31, while the hepatic fat and muscle magnesium summaries have 19 participants in each arm. The registry does not explain this variation, report reasons for missing measurements, or describe the analysis population. Without that information, the potential influence of missing outcome data cannot be evaluated from the record.

The registry does not report detailed eligibility criteria, baseline participant characteristics, adherence, discontinuations, or protocol deviations. It identifies the trial as randomized and double-blind but does not describe sequence generation, allocation concealment, or masking procedures. These omissions limit assessment of comparability and conduct.

The record also does not report the original sample-size justification, statistical analysis plan, multiplicity approach, or any interim analyses. The planning illustration based on observed effects is not a substitute for the trial's own design assumptions. Finally, the posted endpoints cover laboratory and metabolic measures, and the registry does not provide a clinically important threshold or longer-term clinical outcome for interpreting the glucose difference.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate — NCT02665117.
• Registry record last updated 2023-10-25; status last verified 2023-10.
• Results first posted 2023-10-25.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

The registry describes a completed, randomized, double-blind, parallel-group trial of KMgCitrate plus chlorthalidone versus potassium chloride plus chlorthalidone in people with hypertension. Participants first completed a chlorthalidone run-in of 2-3 weeks, followed by 4 months on the assigned supplement. Enrollment is listed as 61, and the primary completion date is 2022-11-04.

The primary endpoint was change in fasting plasma glucose from week 4 to week 16. The posted mean difference was 7.9 mg/dL, with a confidence interval from 1.935 to 13.86 mg/dL and an unadjusted p-value of 0.009. Three secondary outcomes and adverse-event counts are also recorded.

The registry does not report the original statistical plan, missing-data methods, analysis population, or multiplicity approach. The results therefore support a description of the posted comparisons, while broader clinical and mechanistic conclusions remain outside what the record establishes.