Study of Vitamin D Supplementation to Male HIV Sero-positive Patients
NCT00990678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2012-09-17
Summary
The investigators want to investigate if HIV sero-positive males benefit from vitamin D supplementation. The study runs in 16 weeks and the participants are treated with one of three placebo controlled regimes (tablets):
1. Calcium
2. Calcium and 25-hydroxy-vitamin D
3. Calcium and 25-hydroxy-vitamin D and 1,25-dihydroxyvitamin D
The endpoints are:
* Serum vitamin D
* Parathyroid hormone
* ionized calcium
* T-lymphocyte fractions (naïve, mature, Tregs)
* Osteocalcin (bone metabolism)
Conditions
- HIV Seropositive
Interventions
- DRUG
-
Rocaltrol
tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily
- DRUG
-
tablets, vitamin D3, 30 microgram daily
- DRUG
-
Calcium
tablets, 400 mg calcium, 3 times daily
Sponsors & Collaborators
-
Hvidovre University Hospital
lead OTHER
Principal Investigators
-
Ulrich C Bang, M.D. · Dept. of Endocrinology, Hvidovre Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2010-02-28
- Completion
- 2011-01-31
Countries
- Denmark
Study Locations
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