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

King's College London - Guy's and St Thomas' NHS Foundation Trust (UK)0 sites48 target enrollmentNovember 17, 2011

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: King's College London - Guy's and St Thomas' NHS Foundation Trust (UK)
Enrollment: 48
Status: Completed
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

November 17, 2011

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Sponsor

King's College London - Guy's and St Thomas' NHS Foundation Trust (UK)

•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

•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