Studying the effect of vitamin D supplementation in human immunodeficiency virus (HIV) patients who have experienced loss of bone mineral density over time

Phase 4

Completed

• Conditions: Human immunodeficiency virus (HIV); Infections and Infestations; HIV disease resulting in other specified conditions

• Registration Number: ISRCTN08265004
• Lead Sponsor: King's College London - Guy's and St Thomas' NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-17
• Last Update Posted: 15 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Aged between 18 years and 45 years , males and females
2. Documented Positive HIV-1 antibody test and either stable on highly active antiretroviral therapy (HAART) as defined by undetectable viral load and on the same regimen for more than 6 months or treatment naive (HIV+ cohort only) (n=32)
3. Presumed HIV negative C (HIV negative cohort only) (n=16)
4. Ability to give informed consent
5. Willing to use barrier method contraception (condoms) for the duration of the trial
6. Documented Vitamin D deficiency (less than 50 nmol/L within 6 months of screening)
7. Not currently taking Vitamin D supplements, or have taken any Vitamin D supplements within 4 weeks of screening

Exclusion Criteria

1. Pregnancy or breast feeding
2. Patient unlikely to comply with protocol
3. Received vitamin D supplementation within the previous 4 weeks
4. Documented history of renal impairment
5. Any chronic inflammatory condition
6. Documented Hepatitis B or C
7. Documented soya or peanut allergy or hypersensitivity to any of the constituents of Dekristol®
8. Hypercalcaemia or hypercalciuria
9. Pseudohypoparathyroidism

Study & Design

• Study Type: Interventional
• Study Design: Not specified