N/A
N=96
Impact of Vitamin D Repletion in Hemodialysis Patients
Vitamin D Deficiency · End-stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01175798 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Change in 25OH-Vitamin D Level — 15.8; 40.9 ng/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cholecalciferol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mehrotra, Anita, M.D.
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 25OH-Vitamin D Level |
15.8; 40.9 | — |
| SECONDARY Change in Immune Parameters |
— | — |
Summary
Dialysis patients often suffer from defects in their immune system (that part of the body which fights infection). Evidence suggests that Vitamin D deficiency may have a negative effect on immunity, and many dialysis patients are deficient in Vitamin D. We believe that by giving Vitamin D to dialysis patients who are deficient, we may help improve their immune system. This study will test that idea.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Chronic hemodialysis treatments for at least 2 consecutive months
- 25OH-Vitamin D level < 25 ng/mL (inclusion criteria for randomization)
Exclusion Criteria
- History of acute renal failure requiring dialysis with potential for renal recovery
- History of HIV/AIDS
- Inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT01175798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.