| Trial ID: | L1293 |
| Source ID: | NCT04600323
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| Associated Drug: |
Sodium Bicarbonate Tablets
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| Title: |
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT04600323/results
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| Conditions: |
Metabolic Acidosis|Chronic Kidney Disease|Cognitive Dysfunction
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| Interventions: |
DRUG: Sodium Bicarbonate Tablets|DRUG: Placebo
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| Outcome Measures: |
Primary: Change in Cognitive Function Composite Score at 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., Baseline and 12 months|Change in Fluid Cognition Composite Score at 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, baseline and 12 months|Change in Crystallized Cognition Composite Score at 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., baseline and 12 months | Secondary: Change in Cerebrovascular Reactivity at 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)., Baseline and 12 months|Percent Change in Mean Blood Flow Velocity of the Middle Cerebral Artery at 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, Baseline and 12 months
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| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
EARLY_PHASE1
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| Enrollment: |
34
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2021-02-01
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| Completion Date: |
2023-08-30
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| Results First Posted: |
2024-12-20
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| Last Update Posted: |
2024-12-20
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| Locations: |
University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States
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| URL: |
https://clinicaltrials.gov/show/NCT04600323
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