Vitamin D Supplementation in HIV-infected Youth
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Disease Vitamin D Deficiency Hypovitaminosis D Hyperparathyroidism |
Drug: oral cholecalciferol 1000000 UI (vitamin D3) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Vitamin D Status and T Cell Phenotype in HIV-infected Youth Supplemented With Cholecalciferol: a Randomized Clinical Trial. |
- frequency of Hypovitaminosis D [serum 25(OH)D < 30 ng/mL] in the Vitamin D receiving group vs placebo group [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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
- Effect of oral cholecalciferol supplementation on T cell phenotype in vertically HIV-infected youth with stable HIV diseases [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 50 |
| Study Start Date: | April 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitamin D
oral cholecalciferol 1000000 UI (vitamin D3). At 0, 3, 6 and 9 months, the vitamin D group received orally 100000 IU of cholecalciferol suspended in 2 mL of olive oil in sealed plastic syringes labeled with the unique identification numbers. |
Drug: oral cholecalciferol 1000000 UI (vitamin D3)
Other Name: DIBASE - ABIOGEN PHARMA Spa
|
|
Placebo Comparator: placebo
placebo At 0, 3, 6 and 9 months, the placebo group received 2 mL of olive oil, in sealed plastic syringes labeled with the unique identification numbers. |
Drug: Placebo |
Detailed Description:
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)
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01656070
| Italy | |
| Department of Paediatrics - L. Sacco Hospital | |
| Milan, Italy, 20157 | |
| Principal Investigator: | Gian Vincenzo Zuccotti, Professor | Department of Paediatrics, L. Sacco Hospital, University of Milan, Milan, Italy |
More Information
Publications:
| Responsible Party: | Gian Vincenzo Zuccotti, Gian Vincenzo Zuccotti, Associate Professor of Pediatrics, Chief of Department of Pediatrics at L. Sacco Hospital, University of Milan |
| ClinicalTrials.gov Identifier: | NCT01656070 History of Changes |
| Other Study ID Numbers: | HLS02/2011-1.0-09-11-2010, 2011-000593-54 |
| Study First Received: | July 31, 2012 |
| Last Updated: | August 1, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by University of Milan:
|
HIV children adolescents |
Vitamin D immunity T cell phenotype |
Additional relevant MeSH terms:
|
Hyperparathyroidism Vitamin D Deficiency Avitaminosis Deficiency Diseases Endocrine System Diseases Malnutrition Nutrition Disorders Parathyroid Diseases Cholecalciferol |
Ergocalciferols Vitamin D Vitamins Bone Density Conservation Agents Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015