Vitamin D Supplementation in HIV-infected Youth
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| ClinicalTrials.gov Identifier: NCT01656070 |
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Recruitment Status
:
Completed
First Posted
: August 2, 2012
Last Update Posted
: August 2, 2012
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Disease Vitamin D Deficiency Hypovitaminosis D Hyperparathyroidism | Drug: oral cholecalciferol 1000000 UI (vitamin D3) Drug: Placebo | Phase 2 |
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)
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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. |
| Study Start Date : | April 2011 |
| Actual Primary Completion Date : | July 2012 |
| Actual Study Completion Date : | July 2012 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
- frequency of Hypovitaminosis D [serum 25(OH)D < 30 ng/mL] in the Vitamin D receiving group vs placebo group [ Time Frame: 12 months ]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 ]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.
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| Ages Eligible for Study: | up to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 ( EudraCT Number ) |
| First Posted: | August 2, 2012 Key Record Dates |
| Last Update Posted: | August 2, 2012 |
| Last Verified: | August 2012 |
Keywords provided by Gian Vincenzo Zuccotti, University of Milan:
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HIV children adolescents |
Vitamin D immunity T cell phenotype |
Additional relevant MeSH terms:
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Vitamin D Deficiency Hyperparathyroidism Acquired Immunodeficiency Syndrome HIV Infections Avitaminosis Rickets Deficiency Diseases Malnutrition Nutrition Disorders Parathyroid Diseases Endocrine System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Calcium Metabolism Disorders Vitamins Vitamin D Ergocalciferols Cholecalciferol Micronutrients |