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

HIV Seropositive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990678
• Other study ID #: HH-JEBJ-HIVstudy
• Secondary ID: EudraCT 2006-005
• Status: Completed
• Phase: N/A
• First received: October 6, 2009
• Last updated: September 13, 2012
• Start date: April 2008
• Est. completion date: January 2011

Study information

• Verified date: September 2012
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Seropositive
• HIV Seropositivity

Intervention

Drug:
• Rocaltrol
tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily
• Vitamin D
tablets, vitamin D3, 30 microgram daily
• Calcium
tablets, 400 mg calcium, 3 times daily

Locations

Country	Name	City	State
Denmark	Dept. of endocrinology, Hvidovre Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum-vitamin D metabolites		week 0	Yes
Primary	serum-vitamin D metabolites		week 2	Yes
Primary	serum-vitamin D metabolites		week 4	Yes
Primary	serum-vitamin D metabolites		week 8	Yes
Primary	serum-vitamin D metabolites		week 12	Yes
Primary	serum-vitamin D metabolites		week 16	Yes
Secondary	T-lymphocyte fractions Parathyroid hormone ionized calcium		week 0	Yes
Secondary	T-lymphocyte fractions Parathyroid hormone ionized calcium		week 2	Yes
Secondary	T-lymphocyte fractions Parathyroid hormone ionized calcium		week 4	Yes
Secondary	T-lymphocyte fractions Parathyroid hormone ionized calcium		week 8	Yes
Secondary	T-lymphocyte fractions Parathyroid hormone ionized calcium		week 12	Yes
Secondary	T-lymphocyte fractions Parathyroid hormone ionized calcium		week 16	Yes