Vitamin D Supplementation in HIV-infected Youth

NCT01656070 | Completed Phase 2

• 2 other identifiers: HLS02/2011-1.0-09-11-20102011-000593-54
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Disease; Vitamin D Deficiency; Hypovitaminosis D; Hyperparathyroidism

Keywords

HIV; children; adolescents; Vitamin D; immunity; T cell phenotype

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Effect of oral cholecalciferol supplementation on T cell phenotype in vertically HIV-infected youth with stable HIV diseases

  12 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

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)

placebo

PLACEBO COMPARATOR

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

Interventions

oral cholecalciferol 1000000 UI (vitamin D3) DRUG

Also known as: DIBASE - ABIOGEN PHARMA Spa

Vitamin D

Placebo DRUG

placebo

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Vertically acquired HIV infection
• age \< 30 years
• serum 25(OH)D concentration \< 30 ng/mL
• signed written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Department of Paediatrics - L. Sacco Hospital

Milan, 20157, Italy

Location

Related Publications (33)

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Vitamin D Deficiency; Hyperparathyroidism

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Gian Vincenzo Zuccotti, Professor

  Department of Paediatrics, L. Sacco Hospital, University of Milan, Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gian Vincenzo Zuccotti, Associate Professor of Pediatrics, Chief of Department of Pediatrics at L. Sacco Hospital

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 2, 2012
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

IT (1)