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Completed

NCT Number: NCT01523496

Vitamin D Supplementation in HIV Youth

The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.

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Key information

Conditions

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

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Emory Children's Center, Atlanta, Georgia, United States

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About this study

The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 8-25
  • Documented HIV-1 infection
  • On stable antiretroviral therapy for > 3 months
  • Cumulative antiretroviral therapy of at least 6 months
  • 25(OH)D level < 30 ng/ml at screening

Exclusion criteria

  • > 400 IU daily regular vitamin D intake
  • Parathyroid/calcium disorders
  • Active malignancy
  • Pregnancy/intent to become pregnant/breastfeeding
  • Chronic infectious/inflammatory conditions
  • Creatinine clearance < 50 ml/min
  • Hemoglobin < 9.0 g/dL
  • Aspartate aminotransferase and alanine aminotransferase > 2.5 upper limit of normal
  • Diabetes requiring hypoglycemic agents
  • Known coronary artery disease
  • Inability to swallow pills

Treatment and study plan

Vitamin D control dose

Drug

18,000 IU per month

Other names: 25(OH)D3 low dose

Vitamin D supplementation-

Drug

60,000 IU per month(medium dose) or 120,000 IU/month(high dose)

Other names: 25(OH)D3 medium dose or 25(OH)high dose

Primary outcomes

  1. Changes in Serum 25(OH)D3 Levels

    Time frame: 6 months

    Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )

Secondary outcomes

  1. Changes in Vitamin D Binding Protein (VDBP)

    Time frame: 6 months

    Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Emory University

Registry information

Official study title

Vitamin D Supplementation and HIV-related Complications in Children and Young Adults

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 1, 2012
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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