Trial · NCT04600323

Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD

NCT04600323, Early phase 1, Completed, University of Colorado, Denver; results first posted 2024-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD. Trials, record NCT04600323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04600323

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD
NCT number: NCT04600323
Status: Completed
Phases: Early phase 1
Enrollment: 34 participants, actual
Lead sponsor: University of Colorado, Denver
Conditions: Metabolic Acidosis, Chronic Kidney Disease, Cognitive Dysfunction
Interventions: Sodium Bicarbonate Tablets, Placebo
First posted: 2020-10-23
Last updated: 2024-12-20
Results first posted: 2024-12-20

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Cognitive Function Composite Score at 12 Months	Baseline and 12 months	Cognitive function will be determined using the NIH Toolbox-Cognition Battery computerized tests. The Cognitive function composite score is based on the average of the Fluid and Crystallized composites. It is derived by averaging the Fluid and Crystallized standard scores, then deriving standard scores based on this new distribution. Fully Corrected T-scores are adjusted for for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.
Primary	Change in Fluid Cognition Composite Score at 12 Months	baseline and 12 months	NIH Toolbox will be used to assess fluid cognition composite score. This score includes all the tests that are measuring fluid ability: Flanker, Dimensional Change, Picture sequence memory, list sorting and pattern comparison. The composite score is derived by averaging the standard scores of each of the measures. Fully Corrected T-scores are adjusted for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. A fully corrected T-score at or near 50 (population mean with standard deviation of 10) indicates ability that is average compared with others nationally and one below 40 suggests the possibility of cognitive impairment. N
Primary	Change in Crystallized Cognition Composite Score at 12 Months	baseline and 12 months	NIH Toolbox will be used to assess crystallized cognition composite score. This composite score includes the picture vocabulary and reading tests. The composite score is derived by averaging the standard scores of each of the measure, and then driving standard scores based on this new distribution. Fully Corrected T-scores are adjusted for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. A fully corrected T-score at or near 50 (population mean with standard deviation of 10) indicates ability that is average compared with others nationally as the mean T-score is 50 nationally. A score higher than 50 indicates better crystallized cognition.
Secondary	Change in Cerebrovascular Reactivity at 12 Months	Baseline and 12 months	Relative cerebrovascular reactivity was calculated as % change in mean blood flow velocity of the middle cerebral artery/(hypercapnia breath-by-breath end-tidal partial pressure of CO2 (ETCO2) minus resting ETCO2).
Secondary	Percent Change in Mean Blood Flow Velocity of the Middle Cerebral Artery at 12 Months	Baseline and 12 months	Measured using Transcranial Doppler Ultrasonography in response to a vasodilatory hypercapnic challenge.The change in mean blood flow velocity of the middle cerebral artery (MVMCA) was computed as the difference between hypercapnic MVMCA and normocapnic MVMCA

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Cognitive Function Composite Score at 12 Months	Baseline and 12 months	T-score	MEAN
PRIMARY	Change in Fluid Cognition Composite Score at 12 Months	baseline and 12 months	T-score	MEAN
PRIMARY	Change in Crystallized Cognition Composite Score at 12 Months	baseline and 12 months	T-score	MEAN
SECONDARY	Change in Cerebrovascular Reactivity at 12 Months	Baseline and 12 months	percent change/mmHg	MEAN
SECONDARY	Percent Change in Mean Blood Flow Velocity of the Middle Cerebral Artery at 12 Months	Baseline and 12 months	percent change	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Cognitive Function Composite Score at 12 Months	Placebo	Baseline	52.3	Standard Deviation 8.8	T-score
Change in Cognitive Function Composite Score at 12 Months	Sodium Bicarbonate	Baseline	47.3	Standard Deviation 8.5	T-score
Change in Cognitive Function Composite Score at 12 Months	Placebo	12 months	53.5	Standard Deviation 8.5	T-score
Change in Cognitive Function Composite Score at 12 Months	Sodium Bicarbonate	12 months	49.3	Standard Deviation 11.0	T-score
Change in Fluid Cognition Composite Score at 12 Months	Placebo	Baseline	52.1	Standard Deviation 10.8	T-score
Change in Fluid Cognition Composite Score at 12 Months	Sodium Bicarbonate	Baseline	44.7	Standard Deviation 8.7	T-score
Change in Fluid Cognition Composite Score at 12 Months	Placebo	12 months	53.0	Standard Deviation 9.4	T-score
Change in Fluid Cognition Composite Score at 12 Months	Sodium Bicarbonate	12 months	46.9	Standard Deviation 11.7	T-score
Change in Crystallized Cognition Composite Score at 12 Months	Placebo	Baseline	52.8	Standard Deviation 8.3	T-score
Change in Crystallized Cognition Composite Score at 12 Months	Sodium Bicarbonate	Baseline	49.6	Standard Deviation 8.0	T-score

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	16
Overall Study	STARTED	Sodium Bicarbonate	18
Overall Study	COMPLETED	Placebo	16
Overall Study	COMPLETED	Sodium Bicarbonate	17
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Sodium Bicarbonate	1

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dialysis initiation	Renal and urinary disorders	Placebo	0	16	0
other	Dialysis initiation	Renal and urinary disorders	Sodium Bicarbonate	2	18	2
other	New Lower Extremity Edema	Cardiac disorders	Placebo	2	16	2
other	New Lower Extremity Edema	Cardiac disorders	Sodium Bicarbonate	3	18	3
other	Increase in antihypertensive therapy	Cardiac disorders	Placebo	4	16	4
other	Increase in antihypertensive therapy	Cardiac disorders	Sodium Bicarbonate	4	18	4
other	Increase in diuretic therapy	Cardiac disorders	Placebo	0	16	0
other	Increase in diuretic therapy	Cardiac disorders	Sodium Bicarbonate	3	18	3
other	High serum bicarbonate level	Renal and urinary disorders	Placebo	0	16	0
other	High serum bicarbonate level	Renal and urinary disorders	Sodium Bicarbonate	1	18	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	16
Total, all-cause mortality	Sodium Bicarbonate	0	18
Total, other adverse events	Placebo	6	16
Total, other adverse events	Sodium Bicarbonate	13	18
Total, serious adverse events	Placebo	7	16
Total, serious adverse events	Sodium Bicarbonate	6	18

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37889573	DERIVED	PubMed
40797182	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21AG068657	Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD	KENDRICK, JESSICA B	UNIVERSITY OF COLORADO DENVER	NATIONAL INSTITUTE ON AGING	2020

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sodium Bicarbonate vs Placebo: deaths from any cause	Trial comparisons
Sodium Bicarbonate vs Placebo: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Picture Order Memory Test	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04600323

GET https://conductscience.org/api/trials/v1/NCT04600323/registered

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