MedTrace Logo

Vitamin D Supplementation in HIV-infected Youth

NCT01656070 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-08-02

No results posted yet for this study

Summary

Along with its effects on bone metabolism, vitamin D is an important modulator of the immune system. Experimental studies have shown that the active metabolite of vitamin D \[1,25(OH)2D\] is able to skew the T cell compartment into a more anti-inflammatory state, with inhibition of Th1 and Th17 cells and promotion of Th2 and T regulatory subsets.

In the context of HIV infection, in which Th1 subpopulations are devoted to inhibit viral replication, any alteration of the Th1/Th2 balance would be of concern.

The aim of this Randomized Controlled Trial is to test wether oral supplementation with cholecalciferol could be able: 1) to improve vitamin D status and, 2) to play an immunomodulatory role, in vertically HIV-infected children and young adults with hypovitaminosis D.

Conditions

  • HIV Disease
  • Vitamin D Deficiency
  • Hypovitaminosis D
  • Hyperparathyroidism

Interventions

DRUG

oral cholecalciferol 1000000 UI (vitamin D3)

DRUG

Placebo

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Gian Vincenzo Zuccotti, Professor · Department of Paediatrics, L. Sacco Hospital, University of Milan, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656070 on ClinicalTrials.gov