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Vitamin D Dose Finding Study

NCT01092338 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2013-09-18

Study results available
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Summary

Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this will overcome the critical barrier for use of vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit D supplementation may prove to be an effective and feasible treatment for symptoms and prevention of side effects for people of all ages living with HIV/AIDS in the US and around the world.

Conditions

  • HIV Infections
  • AIDS

Interventions

DRUG

Cholecalciferol (Vit D3)

To test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement (capsules or liquid) over a 3-month period in 44 children, adolescents and adults with HIV/AIDS.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Children's Hospital of Philadelphia

    lead OTHER

Principal Investigators

  • Virginia Stallings, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092338 on ClinicalTrials.gov