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.
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 |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 30 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Department of Paediatrics - L. Sacco Hospital | Milan |
Lead Sponsor | Collaborator |
---|---|
University of Milan |
Italy,
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* Note: There are 33 references in all — Click here to view all references
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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