Overview

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.