This study aims to look at the effect of a high dose of Vitamin D on bone mineral density in HIV patients

Phase 1

• Conditions: HIV; MedDRA version: 20.0 Level: PT Classification code 10020188 Term: HIV test positive System Organ Class: 10022891 - Investigations; MedDRA version: 20.0 Level: LLT Classification code 10063206 Term: HIV-1 test positive System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-023122-21-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-10
• Study Completion: 2013-02-28
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified