Vitamin D Supplementation in HIV-infected Youth

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milan
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Vertically acquired HIV infection

• age < 30 years

• serum 25(OH)D concentration < 30 ng/mL

• signed written informed consent

Exclusion Criteria:

• hyperparathyroidism, as detected by an intact serum parathyroid hormone (PTH) ≥ 65 pg/mL

• Black ethnic group

• any supplementation with vitamin D in the previous 12 months

• use of any treatment known to alter vitamin D status in the previous 6 months (excluding ARV)

• any concomitant severe illness.