| Trial ID: | L0140 |
| Source ID: | NCT02427594
|
| Associated Drug: |
Sodium Bicarbonate
|
| Title: |
Acid-Base Compensation in Chronic Kidney Disease
|
| Acronym: |
ABC
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: Sodium bicarbonate|OTHER: Controlled diet
|
| Outcome Measures: |
Primary: Change in ambulatory blood pressure, Change in mean 24 hour systolic and diastolic blood pressure comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period., Measured at the end of each week of intervention (i.e. one week apart)|Change in urine net acid excretion, Change in urine net acid excretion comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period., Urine net acid excretion will be measured at three timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in) | Secondary: Change in clinic blood pressure, Change in average of three readings of systolic and diastolic blood pressure will be evaluated comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period., Clinic blood pressure will be measured at multiple timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in)|Change in plasma nitric oxide metabolites, Change in nitric oxide metabolites comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period., Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks | Other: Differences in metabolomic profiles, Differences in metabolites will be evaluated comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period., Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks
|
| Sponsor/Collaborators: |
Sponsor: Duke University | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
14
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2015-04
|
| Completion Date: |
2017-08-25
|
| Results First Posted: |
|
| Last Update Posted: |
2017-08-30
|
| Locations: |
Duke University School of Medicine, Durham, North Carolina, 27710, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02427594
|
