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

Pro-Bono 2- A prospective study of loss of bone mineral density in patients with HIV over time: implications for clinical practice and therapeutic options: Vitamin D sub study. - Pro-Bono-2 Vitamin D SubStudy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023122-21-GB

Enrollment

Registered

2011-10-10

Start date

2011-11-08

Completion date

Unknown

Last updated

2019-02-28

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

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

Interventions

Trade Name: Dekristol Pharmaceutical Form: Capsule, soft Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM) Concentration unit: IU internati

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effects of vit D supplementation on markers of the immune system, specifically CD4+CD25+ T-regulatory cells ;Secondary Objective: To determine the benefits of a one high dose of Colecalciferol (200,000 U orally) on serum vit D levels in patients with HIV infection after 12 weeks from commencement of Vitamin D supplementation.;Primary end point(s): The Primary endpoint will be T-regulatory cell numbers at 12 weeks.;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: To determine the effects of vit D supplementation on markers of the immune system, specifically CD4+CD25+ T-regulatory cells ;Secondary Objective: To determine the benefits of a one high dose of Colecalciferol (200,000 U orally) on serum vit D levels in patients with HIV infection after 12 weeks from commencement of Vitamin D supplementation.;Primary end point(s): The Primary endpoint will be T-regulatory cell numbers at 12 weeks.;Timepoint(s) of evaluation of this end point: 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: Serum vitamin D levels at week 4 and 12. Change in immune parameters such as T-regulatory function at weeks 4 and 12, and numbers at 4 weeks. Plasma IL-10, TNF a, IFN ?, IL-17 at 4 and 12 weeks. ;Timepoint(s) of evaluation of this end point: 4 and 12 weeks	—

Countries

United Kingdom

Contacts

Public ContactDr Barry Peters

King's College London

barry.peters@kcl.ac.uk00440207188 7188

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026