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

• Sponsor: Hvidovre University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00990678
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 33
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
HIV Seropositive	Drug: Rocaltrol; Drug: Vitamin D; Drug: Calcium	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Study of Vitamin D Supplementation to Male HIV Sero-positive Patients
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "Strong vitamin D" Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily	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
Active Comparator: Vitamin D calcium 400 mg + 10 microgram Vitamin D3, 3 times daily	Drug: Vitamin D; tablets, vitamin D3, 30 microgram daily; Drug: Calcium; tablets, 400 mg calcium, 3 times daily
Placebo Comparator: Calcium Tablet Calcium 400 mg x 3 daily	Drug: Calcium; tablets, 400 mg calcium, 3 times daily

Outcome Measures

Primary Outcome Measures

1. serum-vitamin D metabolites [week 0]

2. serum-vitamin D metabolites [week 2]

3. serum-vitamin D metabolites [week 4]

4. serum-vitamin D metabolites [week 8]

5. serum-vitamin D metabolites [week 12]

6. serum-vitamin D metabolites [week 16]

Secondary Outcome Measures

1. T-lymphocyte fractions Parathyroid hormone ionized calcium [week 0]

2. T-lymphocyte fractions Parathyroid hormone ionized calcium [week 2]

3. T-lymphocyte fractions Parathyroid hormone ionized calcium [week 4]

4. T-lymphocyte fractions Parathyroid hormone ionized calcium [week 8]

5. T-lymphocyte fractions Parathyroid hormone ionized calcium [week 12]

6. T-lymphocyte fractions Parathyroid hormone ionized calcium [week 16]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of endocrinology, Hvidovre Hospital	Copenhagen		Denmark	2450

Sponsors and Collaborators

• Hvidovre University Hospital

Investigators

• Principal Investigator: Ulrich C Bang, M.D., Dept. of Endocrinology, Hvidovre Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ulrich Bang, M.D., Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT00990678
• Other Study ID Numbers: HH-JEBJ-HIVstudy; EudraCT 2006-005039-40; Danish Health 2612-3303
• First Posted: Oct 7, 2009
• Last Update Posted: Sep 17, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Ulrich Bang, M.D., Hvidovre University Hospital: HIV-1; humans; vitamin D; 1-hydroxy-vitamin D; Rocaltrol; calcium; complementary therapies
• Additional relevant MeSH terms: HIV Seropositivity; Vitamin D; Calcitriol; Calcium

Study Results

No Results Posted as of Sep 17, 2012