| Trial ID: | L0447 |
| Source ID: | NCT01988116
|
| Associated Drug: |
Oral Calcitriol 0.5 Mcg Once Daily For 6 Weeks
|
| Title: |
Effects of Vitamin D Replacement on Hormones Regulating Iron Metabolism in Individuals With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Anemia of Chronic Disease
|
| Interventions: |
DRUG: Oral Calcitriol 0.5 mcg once daily for 6 weeks|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in serum hepcidin levels, At Day 0, Day 3, 1 week, 4 weeks and 6 weeks|Change in soluble hemojuvelin, At Day 0, Day 3, 1 week, 4 weeks and 6 weeks|Change in other indices of iron metabolism, Including, Serum Ferritin, Iron level, Percent transferrin saturation and TIBC, At Day 0, Day 3, 1 week, 4 weeks and 6 weeks | Secondary: Change in serum hemoglobin, At Day 0, Day 3, 1 week, 4 weeks and 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Alabama at Birmingham
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose:
|
| Start Date: |
2013-10
|
| Completion Date: |
2015-06
|
| Results First Posted: |
|
| Last Update Posted: |
2015-08-24
|
| Locations: |
University of Alabama, Birmingham, Alabama, 35294, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01988116
|
