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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990678

Enrollment

Registered

2009-10-07

Start date

2008-04-30

Completion date

2011-01-31

Last updated

2012-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Seropositive

Keywords

HIV-1, humans, vitamin D, 1-hydroxy-vitamin D, Rocaltrol, calcium, complementary therapies

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)

Interventions

DRUGRocaltrol

tablet, Vitamin 1-OH-D3, total 1.25-2.5 mg daily

DRUGVitamin D

tablets, vitamin D3, 30 microgram daily

DRUGCalcium

tablets, 400 mg calcium, 3 times daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
serum-vitamin D metabolites	week 0

Secondary

Measure	Time frame
T-lymphocyte fractions Parathyroid hormone ionized calcium	week 0

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026