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

NCT ID: NCT04600323

Last Updated: 2024-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-08-30

Brief Summary

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This is a pilot, randomized, double-blinded, placebo-controlled, 12-month trial of 50 patients with CKD stage 3b-4 with metabolic acidosis to examine the effect of sodium bicarbonate therapy on cognitive and cerebrovascular function.

Detailed Description

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Conditions

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Metabolic Acidosis Chronic Kidney Disease Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months

Sodium bicarbonate

Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day.

Group Type EXPERIMENTAL

Sodium Bicarbonate Tablets

Intervention Type DRUG

Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months

Interventions

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Sodium Bicarbonate Tablets

Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months

Intervention Type DRUG

Placebo

Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 50-75 years old
* Serum bicarbonate 16-22 mEq/L on 2 separate measurements (at least 1 day apart)
* CKD stage 3b or 4 at time of screening (eGFR 15-44 ml/min/1.73m2)
* Blood pressure \<130/80 mm Hg prior to randomization
* Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Montreal Cognitive Assessment Score \> 24
* No history of stroke
* No history of dementia
* No history of neurologic disease
* Able to provide consent

Exclusion Criteria

* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* Uncontrolled hypertension
* Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
* Factors judged to limit adherence to interventions
* Anticipated initiation of dialysis or kidney transplantation within 12 months
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Chronic use of supplemental oxygen
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Gu F, You Z, Hawkins N, Reddin R, Hamour R, Shapiro A, Coughlan C, Seals D, Furgeson S, Dixon A, Nowak KL, Kendrick J. Effects of sodium bicarbonate therapy on cognitive and cerebrovascular function in midlife and older adults with chronic kidney disease: a pilot randomized trial. BMC Nephrol. 2025 Aug 12;26(1):454. doi: 10.1186/s12882-025-04388-6.

Reference Type DERIVED
PMID: 40797182 (View on PubMed)

Perez L, You Z, Kendrick J. Association of Plant-Based Protein Intake with Cognitive Function in Adults with CKD. Kidney360. 2023 Nov 1;4(11):1554-1561. doi: 10.34067/KID.0000000000000278. Epub 2023 Oct 27.

Reference Type DERIVED
PMID: 37889573 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20-1672

Identifier Type: -

Identifier Source: org_study_id

R21AG068657

Identifier Type: NIH

Identifier Source: secondary_id

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