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 个研究点目标入组 48 人开始时间: 2011年11月17日最近更新: 2018年1月15日

试验速览

暂无简介。

•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

发起方

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