EUCTR2011-000593-54-IT进行中(未招募)不适用
Effect of Vitamin D supplementation in HIV-infected children, adolescents and young adults with hypovitaminosis D.
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2012年3月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
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
- 性别
- All
入选标准
- •Age between 8 and 26 years at the enrolment
- •Plasma vitamin D values < 20 ng/ml for subjects < 18 years
- •Plasma vitamin D values < 30 ng/ml for subjects > 18 years
- •Signed informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hyperparathyroidism, defined as vitamin D3 < than normal levels (< 20 ng/ml for those <18 years; < 30 ng/ml for those > 18 years) and PTH > 65 pg/ml.
- •Hyper or Hypocalcemia: range for age= 9.0-11.0 mg/dL (8-16 years); 8.5 -10.5 mg/dL (> 16 years);
- •African American ethnicity, to avoid bias determined by the different skin vitamin D3 synthesis promoted by sun exposure.
- •Every supplementation with Vitamin D or derived products taken during the 12 months previous to the enrollment.
- •Every drug or substance capable to alter Vitamin D and PTH absorption and/or metabolism, excluding antiretroviral drugs.
- •Severe pathologic associated conditions such as tumoral, renal, cardiovascular or haematological pathologies.
研究者
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