EUCTR2010-023122-21-GB进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
研究者
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