| Trial ID: | L0573 |
| Source ID: | NCT01452412
|
| Associated Drug: |
Sodium Bicarbonate
|
| Title: |
Alkali Therapy in Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01452412/results
|
| Conditions: |
Chronic Kidney Disease|Metabolic Acidosis
|
| Interventions: |
DRUG: Sodium bicarbonate|DRUG: Placebo
|
| Outcome Measures: |
Primary: Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times, Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups., 2 year|DEXA of Wrist, The investigators will evaluate changes in bone mineral density at the wrist., 2 year | Secondary: Hand-grip Strength, Hand-grip strength will be measured in all participants, 2 year|Estimated GFR, Estimated GFR, 2 year|Quality of Life - Physical Function Domain, Short Form- 36 (SF-36) will be performed in all participants. We will evaluate effects on the Physical Function Domain. The Physical Function Domain is scored from 0 to 100 with higher scores meaning better physical functioning., 2 year
|
| Sponsor/Collaborators: |
Sponsor: Albert Einstein College of Medicine | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|National Institutes of Health (NIH)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
149
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-10
|
| Completion Date: |
2016-08
|
| Results First Posted: |
2020-01-07
|
| Last Update Posted: |
2020-01-07
|
| Locations: |
Albert Einstein College of Medicine, Bronx, New York, 10461, United States|Case Western Reserve University, Cleveland, Ohio, 44106, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01452412
|
