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

Study Overview
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Brief Summary
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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): Calcium Calcium and 25-hydroxy-vitamin D 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)

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

Conditions
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HIV Seropositive

Intervention / Treatment
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* Drug: Rocaltrol
* Drug: Vitamin D
* Drug: Calcium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strong vitamin D<br>Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily | Drug: Rocaltrol<br>* tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily<br>Drug: Vitamin D<br>* tablets, vitamin D3, 30 microgram daily<br>Drug: Calcium<br>* tablets, 400 mg calcium, 3 times daily<br>|
| Active Comparator: Vitamin D<br>calcium 400 mg + 10 microgram Vitamin D3, 3 times daily | Drug: Vitamin D<br>* tablets, vitamin D3, 30 microgram daily<br>Drug: Calcium<br>* tablets, 400 mg calcium, 3 times daily<br>|
| Placebo Comparator: Calcium<br>Tablet Calcium 400 mg x 3 daily | Drug: Calcium<br>* tablets, 400 mg calcium, 3 times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum-vitamin D metabolites |  | week 0 | 
| serum-vitamin D metabolites |  | week 2 | 
| serum-vitamin D metabolites |  | week 4 | 
| serum-vitamin D metabolites |  | week 8 | 
| serum-vitamin D metabolites |  | week 12 | 
| serum-vitamin D metabolites |  | week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-lymphocyte fractions Parathyroid hormone ionized calcium |  | week 0 | 
| T-lymphocyte fractions Parathyroid hormone ionized calcium |  | week 2 | 
| T-lymphocyte fractions Parathyroid hormone ionized calcium |  | week 4 | 
| T-lymphocyte fractions Parathyroid hormone ionized calcium |  | week 8 | 
| T-lymphocyte fractions Parathyroid hormone ionized calcium |  | week 12 | 
| T-lymphocyte fractions Parathyroid hormone ionized calcium |  | week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, humans, vitamin D, 1-hydroxy-vitamin D, Rocaltrol, calcium, complementary therapies