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.
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.
There is increasing evidence that hypovitaminosis D is common in the general population.
Low dietary intake of vitamin D and reduced exposure to sunlight are probably the major risk
factors. A high prevalence of hypovitaminosis D has been described in HIV-infected adults,
and children. HIV infection itself and antiretroviral (ARV) treatment may be responsible for
alteration of vitamin D metabolism. For instance, studies have shown a significant decrease
in serum 25-hydroxyvitamin-D [25(OH)D] concentration in adults receiving non-nucleoside
reverse transcriptase inhibitors (NNRTIs). Whatever the cause(s) of hypovitaminosis D,
because of the importance of vitamin D in bone health, randomized controlled trials (RCT)
have been performed to test whether vitamin D supplementation can improve vitamin D status
and bone mineral metabolism in HIV-infected children and adolescents.
Along with its effects on bone metabolism, vitamin D is an important modulator of the immune
system. The vitamin D receptor (VDR) is found in high concentrations in activated T
lymphocytes, in small amounts in monocyte/macrophage cells while B lymphocytes do not
contain detectable amounts of VDR.
Experimental studies have shown that the active di-hydroxylated 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 (Treg) subsets.
In the context of HIV infection, in which Th1 subpopulations are devoted to inhibit viral
replication, 16 any alteration of the Th1/Th2 balance would be of concern.
Although all the biological effects of vitamin D are mediated by the 1,25(OH)2D, it is the
25(OH)D to be routinely quantified because of its longer half-life.17 However, HIV-infected
subjects may have a defective 1α-hydroxylation of 25(OH)D. Thus, it is important to evaluate
the effects of vitamin D supplementation both in terms of 25(OH)D and 1,25(OH)2D responses.
This repeated-measures parallel-group RCT is aimed to test wether a 12-month oral
supplementation with cholecalciferol (vitamin D3) is able: 1) to increase serum 25(OH)D and
1,25(OH)2D levels and, 2) to affect T-cell phenotype in vertically HIV-infected children and
young adults with hypovitaminosis D and stable HIV-disease.
Main outcome: to determine the frequency of hypovitaminosis D at 12-month of follow-up among
subjects supplemented with oral cholecalciferol versus subjects receiving placebo.
Secondary outcome: to investigate correlations - if any - between serum vitamin D
concentration and markers of immune activation (i.e. Th1-, Th2-, Th17- and Treg-lymphocytes
count, T-lymphocyte VDR expression)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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