| Trial ID: | L1344 |
| Source ID: | NCT01175798
|
| Associated Drug: |
Cholecalciferol
|
| Title: |
Impact of Vitamin D Repletion in Hemodialysis Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01175798/results
|
| Conditions: |
Vitamin D Deficiency|End-stage Renal Disease
|
| Interventions: |
DRUG: Cholecalciferol
|
| Outcome Measures: |
Primary: Change in 25OH-Vitamin D Level, Vitamin D deficient study subjects will be randomized to either treatment with 50,000 IU oral 25OH-Vit D weekly or no treatment (standard of care). The primary outcome of change in 25OH-Vit D level will be measured at 6 weeks, 3 months, 6 months, and 12 months., 1 year | Secondary: Change in Immune Parameters, Secondary outcomes to be measured include change in peripheral blood mononuclear cell (PBMC) profile by flow cytometry at 6 and 12 months, change in ELISPOT-based panel of reactive T cell (PRT) readout at 6 and 12 months, change in PMBC cytokine production in response to toll-like-receptor stimulation at 6 and 12 months, and response to influenza vaccination., 1 year
|
| Sponsor/Collaborators: |
Sponsor: Mehrotra, Anita, M.D. | Collaborators: National Kidney Foundation|American Heart Association
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
116
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-08
|
| Completion Date: |
2013-08
|
| Results First Posted: |
2014-09-22
|
| Last Update Posted: |
2014-09-22
|
| Locations: |
Mount Sinai School of Medicine, New York, New York, 10029, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01175798
|
