Study of Vitamin D Supplementation to Male HIV Sero-positive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- serum-vitamin D metabolites
研究概览
简要总结
The investigators want to investigate if HIV sero-positive males benefit from vitamin D supplementation. The study runs in 16 weeks and the participants are treated with one of three placebo controlled regimes (tablets):
- Calcium
- Calcium and 25-hydroxy-vitamin D
- Calcium and 25-hydroxy-vitamin D and 1,25-dihydroxyvitamin D
The endpoints are:
- Serum vitamin D
- Parathyroid hormone
- ionized calcium
- T-lymphocyte fractions (naïve, mature, Tregs)
- Osteocalcin (bone metabolism)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •HIV-positive
- •at least 18 years old
- •receiving HiglyActiveAntiRetroviral Therapy (HAART)
排除标准
- •hypercalcemia
- •tuberculosis
- •osteoporosis or other bone disease
- •cancer with bone metastasis
研究组 & 干预措施
"Strong vitamin D"
Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily
干预措施: Rocaltrol (Drug)
"Strong vitamin D"
Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily
干预措施: Vitamin D (Drug)
"Strong vitamin D"
Calcium 400 Mg + Vitamin D3 10 microg, 3 times daily Rocaltrol 1.25 mg to 2.5 mg daily
干预措施: Calcium (Drug)
Vitamin D
calcium 400 mg + 10 microgram Vitamin D3, 3 times daily
干预措施: Vitamin D (Drug)
Vitamin D
calcium 400 mg + 10 microgram Vitamin D3, 3 times daily
干预措施: Calcium (Drug)
Calcium
Tablet Calcium 400 mg x 3 daily
干预措施: Calcium (Drug)
结局指标
主要结局
serum-vitamin D metabolites
时间窗: week 16
次要结局
- T-lymphocyte fractions Parathyroid hormone ionized calcium(week 16)
研究者
Ulrich Bang
M.D.
Hvidovre University Hospital