Children and young adults with HIV infection and hypovitaminosis D. MedDRA version: 14.1 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: HLGT Classification code 10047635 Term: Vitamin related disorders System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: DIBASE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Colecalciferol
Concentration unit: U/ml unit(s)/millilitre
Concentration number: 100000-
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age between 8 and 26 years at the enrolment • Plasma vitamin D values 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
Exclusion criteria: • Hyperparathyroidism, defined as vitamin D3 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, 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 30 ng/ml for those > 18 years). | — |
Countries
Italy
Outcome results
None listed