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NCT01656070 Clinical Trial

Vitamin D Supplementation in HIV-infected Youth

Vitamin D Deficiency Clinical Trial

Official title:
Vitamin D Status and T Cell Phenotype in HIV-infected Youth Supplemented With Cholecalciferol: a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01656070
Other study ID # HLS02/2011-1.0-09-11-2010
Secondary ID 2011-000593-54
Status Completed
Phase Phase 2
First received July 31, 2012
Last updated August 1, 2012
Start date April 2011
Est. completion date July 2012

Study information
Verified date August 2012
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial 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.

Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• oral cholecalciferol 1000000 UI (vitamin D3)

• Placebo

Locations
Country Name City State
Italy Department of Paediatrics - L. Sacco Hospital Milan

Sponsors (1)
Lead Sponsor Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (33)

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Outcome
Type Measure Description Time frame Safety issue
Primary frequency of Hypovitaminosis D [serum 25(OH)D < 30 ng/mL] in the Vitamin D receiving group vs placebo group Vertically HIV-infected patients aged <30 years and with serum 25(OH)D < 30 ng/mL were randomized into the vitamin D or placebo group. At baseline (0 months), 3, 6 and 9 months, the intervention group received orally 100000 IU of cholecalciferol. Serum 25(OH)D, 1,25(OH)2D, PTH and CD4+ T cells were assessed 3 months before baseline, at 0, 3, 6, 9 and 12 months, while Th1-, Th2-, Th17- and Treg-subsets and T-lymphocyte vitamin D receptor at 0, 3 and 12 months 12 months Yes
Secondary Effect of oral cholecalciferol supplementation on T cell phenotype in vertically HIV-infected youth with stable HIV diseases Vertically HIV-infected patients aged <30 years and with serum 25(OH)D < 30 ng/mL were randomized into the vitamin D or placebo group. At baseline (0 months), 3, 6 and 9 months, the intervention group received orally 100000 IU of cholecalciferol. CD4+ T-cells were assessed 3 months before enrollment (-3 months), at baseline (0 months) and at each visit thereafter (3, 6, 9 and 12 months). T-lymphocyte VDR expression and Th1-, Th2-, Th17- and Treg-lymphocytes were measured at 0, 3 and 12 months. 12 months Yes
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