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

No results posted yet for this study

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

Vitamin D

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990678 on ClinicalTrials.gov