Effect of Vitamin D supplementation in HIV-infected children, adolescents and young adults with hypovitaminosis D.

Conditions: Children and young adults with HIV infection and hypovitaminosis D.
MedDRA version: 14.1Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 14.1Level: HLGTClassification code 10047635Term: Vitamin related disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders

Registration Number: EUCTR2011-000593-54-IT

Lead Sponsor: AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Secondary objective will be the grade of immunoactivation and values of bone formation and reabsorption, examined through specific immunologic and biochemical markers.;Primary end point(s): Primary endpoint is the percentage of patients with hypovitaminosis D at 12 months.;Main Objective: A single dose of high concentrated (100.000 UI) colecalciferol, orally administered every 3 months, during 12 months, <br>to HIV infected patients selected for insufficient values of plasmatic vitamin-D, might re-establish normal vitamin-D levels considered for age (>20 ng/ml for those <18 years; > 30 ng/ml for those > 18 years).

Secondary Outcome Measures