跳至主要内容
临床试验/EUCTR2011-000593-54-IT
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

发起方
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

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