Study of Vitamin D Supplementation to Male HIV Sero-positive Patients

Not Applicable

Completed

• Conditions: HIV Seropositive
• Interventions: Drug: Rocaltrol; Drug: Vitamin D; Drug: Calcium

• Registration Number: NCT00990678
• Lead Sponsor: Hvidovre University Hospital

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Primary Completion: 2010-02
• Study Completion: 2011-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• male
• HIV-positive
• at least 18 years old
• receiving HiglyActiveAntiRetroviral Therapy (HAART)

Exclusion Criteria

• hypercalcemia
• tuberculosis
• osteoporosis or other bone disease
• cancer with bone metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Strong vitamin D"	Rocaltrol	Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily
"Strong vitamin D"	Vitamin D	Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily
"Strong vitamin D"	Calcium	Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily
Vitamin D	Vitamin D	calcium 400 mg + 10 microgram Vitamin D3, 3 times daily
Calcium	Calcium	Tablet Calcium 400 mg x 3 daily
Vitamin D	Calcium	calcium 400 mg + 10 microgram Vitamin D3, 3 times daily

Primary Outcome Measures

Name	Time	Method
serum-vitamin D metabolites	week 16

Secondary Outcome Measures

Name	Time	Method
T-lymphocyte fractions Parathyroid hormone ionized calcium	week 16

Trial Locations

Locations (1)

Dept. of endocrinology, Hvidovre Hospital; 🇩🇰 Copenhagen, Denmark