Clinical Trial Details
| Trial ID: | L1164 |
| Source ID: | NCT03073369 |
| Associated Drug: | Ergocalciferol 50000 Unt |
| Title: | Effect of Ergocalciferol on Iron Metabolism in Individuals With Chronic Kidney Disease |
| Acronym: | |
| Status: | WITHDRAWN |
| Study Results: | NO |
| Results: | |
| Conditions: | CKD|Chronic Kidney Diseases|Hepcidin|Ergocalciferol|Vitamin D|Iron-deficiency|Anemia |
| Interventions: | DRUG: Ergocalciferol 50000 UNT|DRUG: Placebo |
| Outcome Measures: | Primary: Change in serum hepcidin levels, Difference in change in serum hepcidin levels (ng/ml) over time between the two groups, At Day 0, Day 3, 1 week, 4 weeks and 6 weeks | Secondary: Change in serum hemoglobin level, Difference in change in serum hemoglobin levels (g/dL) over time between the two groups, At Day 0, Day 3, 1 week, 4 weeks and 6 weeks|Change in serum ferritin level, Difference in change in serum ferritin levels (ng/ml) over time between the two groups, At Day 0, Day 3, 1 week, 4 weeks and 6 weeks|Change in percent transferrin saturation, Difference in change in percent transferrin saturation (%) over time between the two groups, At Day 0, Day 3, 1 week, 4 weeks and 6 weeks|Change in serum iron level, Difference in change in serum iron levels (mcg/dL) over time between the two groups, At Day 0, Day 3, 1 week, 4 weeks and 6 weeks |
| Sponsor/Collaborators: | Sponsor: University of Alabama at Birmingham | Collaborators: American Heart Association |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 0 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2018-01-01 |
| Completion Date: | 2018-12 |
| Results First Posted: | |
| Last Update Posted: | 2018-03-15 |
| Locations: | University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States |
| URL: | https://clinicaltrials.gov/show/NCT03073369 |
