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

Hvidovre University Hospital

Status: Completed

Conditions: HIV Seropositive

Treatments: Drug: Vitamin D; Drug: Rocaltrol; Drug: Calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT00990678

EudraCT 2006-005039-40

HH-JEBJ-HIVstudy

Danish Health 2612-3303

Details and patient eligibility

About

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)

Enrollment: 60 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 3 patient groups, including a placebo group

"Strong vitamin D"

Experimental group

Description:

Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily

Treatment:

Drug: Rocaltrol

Drug: Vitamin D

Drug: Calcium

Vitamin D

Active Comparator group

Description:

calcium 400 mg + 10 microgram Vitamin D3, 3 times daily

Treatment:

Drug: Vitamin D

Drug: Calcium

Calcium

Placebo Comparator group

Description:

Tablet Calcium 400 mg x 3 daily

Treatment:

Drug: Calcium