The Effect of Vitamin D and Calcium on Bone in Pediatric HIV
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Total Body Bone Mineral Content
研究概览
简要总结
We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations, is common in children and adolescents with HIV infection. To determine whether vitamin D and calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in HIV-infected children and adolescents, we propose a double-blind, randomized, placebo-controlled trial comparing supplementation with oral vitamin D and calcium to placebo.
The specific aims of this project are to:
- Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in HIV-infected children.
We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected children who receive supplementation with vitamin D and calcium. This hypothesis will be tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry (DXA), after one and two years of treatment in HIV-infected children and adolescents receiving vitamin D and calcium supplementation compared to those receiving placebo. 2. Determine the effect of HIV infection and vitamin D and calcium supplementation on indices of mineral metabolism and markers of bone turnover.
We hypothesize that indices of mineral metabolism and markers of bone formation and resorption will return toward normal in HIV-infected children and adolescents who are randomized to receive vitamin D and calcium supplementation. We will test these hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone turnover markers in HIV-infected children and adolescents receiving vitamin D and calcium supplement versus those receiving placebo 3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and adolescents receiving HAART.
We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an important determinant of bone mass in HIV-infected children and adolescents receiving HAART. We will test this hypothesis by evaluating whether measurements of bone mass are associated with vitamin D stores, as measured by serum 25-hydroxyvitamin D levels and other indices of mineral metabolism, in treated HAART-treated HIV-infected children and adolescents.
详细描述
A.1.a. Introduction This is a prospective, randomized, double-blind clinical trial designed to evaluate the effect of 24 months of supplementation with vitamin D3 and calcium on bone mass accrual in HIV-infected children and adolescents.
A.1.b. Subject recruitment i. HIV-infected subjects on will be enrolled by Co-Investigators from among HIV-infected children and adolescents who receive treatment at participating sites who meet inclusion and exclusion criteria.
A.1.c. Measurements:
Blood for measurement of serum 25(OH)D levels will be obtained from all HIV-infected children and adolescents by the participating clinical sites. Samples will be analyzed and the results known in advance of the cross-sectional study visit. Serum 25(OH)D levels will be used to select participants. The following measures will be performed:
Medical history, including medications Pregnancy test for females of child bearing capacity Height and weight Assessment of pubertal stage Assessment of dietary intake of calcium and vitamin D Assessment of physical activity Determination of total body bone mineral content (TBBMC), total body bone mineral density (TBBBMD), spinal BMC and BMD, and bone age radiograph Fasting morning blood draw for indices of mineral metabolism: serum calcium, phosphate, albumin, total alkaline phosphatase activity, 25(OH)D, 1,25(OH)2D, iPTH, urinary calcium and creatinine.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, parent, or legal guardian able and willing to provide informed consent/assent.
- •Subject able and willing to comply with requirements of study HIV-infected subjects must have diagnosis confirmed with one or more of the following tests: 1) HIV DNA Polymerase chain reaction or HIV culture performed at any age; 2) Age >18 months, licensed ELISA with confirmatory Western Blot.
排除标准
- •Patients with history of atraumatic fractures, known renal or liver disease, known malabsorption syndrome, or inflammatory bowel disease.
- •Use of corticosteroids, exculding inhaled steroids (current or within past 6 months) Current use of anticonvulsant drug Daily cigarette smoking Daily consumption of alcohol containing beverages Current use of tenofovir
结局指标
主要结局
Total Body Bone Mineral Content
时间窗: Entry, 12 and 24 months
次要结局
- Additional outcomes that will be evaluated include the effect of Vitamin D and calcium on serum and urine calcium and creatinine and markers of bone turnover(Monthly for first year, and quarterly in year.Bone turnover measured at baseline, 2. 3, 6, 12, and 24 months)