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

NCT04600323 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-12-20

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Sodium Bicarbonate Tablets

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

DRUG

Placebo

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

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-08-30
Completion
2023-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04600323 on ClinicalTrials.gov