Vitamin D Supplementation in HIV

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ClinicalTrials.gov Identifier: NCT01475890

Recruitment Status : Completed

First Posted : November 22, 2011

Last Update Posted : March 17, 2017

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Center for Complementary and Integrative Health (NCCIH)

Information provided by (Responsible Party):

Children's Hospital of Philadelphia

Study Description

Brief Summary:

The purpose of this study is to evaluate safety and efficacy of vitamin D supplementation in children, adolescents and young adults with Human Immunodeficiency Virus and acquired immunodeficiency syndrome (HIV/AIDS). The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB 09-007332.

Condition or disease	Intervention/treatment	Phase
HIV-infection/Aids	Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo	Phase 2 Phase 3

Detailed Description:

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.

The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB 09-007332 in 58 subjects with both Perinatally Acquired (PA) and Behaviorally Acquired (BA) HIV/AIDS to assess the long-term safety in terms of serum calcium and 25OHD concentrations, and efficacy in terms of the effect of vit D supplementation on 25OHD, cathelicidin, growth (pre- and peripubertal participants), body composition, bone, muscle, immune and inflammatory status and HIV/AIDS disease severity and progression.

Primary Hypotheses:

H1: Vit D supplementation is safe and does not result in an increased incidence of elevated serum calcium (above age-specific range) associated with elevated serum 25OHD (>160 ng/mL) in treated subjects compared with the subjects receiving placebo.

H2: Vit D supplementation is significantly associated with both increased 25D and cathelicidin in treated subjects compared with subjects receiving placebo.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	58 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Safe and Effective Vitamin D Supplementation in HIV
Study Start Date :	July 2011
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 7000IU/day 29 subjects will be randomized to receive 7000IU/day of vitamin D3.	Dietary Supplement: Vitamin D3 7000IU per day of vitamin D3 for 12 months.
Placebo Comparator: Placebo 29 subjects will be randomized to receive placebo.	Dietary Supplement: Placebo Once a day for 12 months.

Outcome Measures

Primary Outcome Measures :

Vitamin D Supplementation Safety [ Time Frame: 12 months ]
elevated serum calcium (above age-specific range) associated with elevated serum 25D (>160 ng/mL)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	5 Years to 24 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV seropositive diagnosed with standard techniques
Age for PA Group: 5.0 to 24.9 y
Age for BA Group: 15.0 to 24.9 y
In usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment)
Subject and/or family commitment to the 12-month study

Exclusion Criteria:

Other chronic health conditions that may affect growth, dietary intake, and/or nutritional status
Pregnancy
Participation in another HIV intervention study with impact on 25D serum concentrations
Use of vit D3 supplementation for the purpose of treating vit D deficiency
Use of vit D3 supplementation not part of a prescribed treatment plan for vit D deficiency (subjects willing to discontinue supplementation will become eligible after a minimum of a 2 month washout period)
Non-English Speaking

Contacts and Locations

Information from the National Library of Medicine

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): NCT01475890

Locations


United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

National Institutes of Health (NIH)

National Center for Complementary and Integrative Health (NCCIH)

Investigators


Principal Investigator:	Virginia A Stallings, MD	Children's Hospital of Philadelphia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rovner AJ, Stallings VA, Rutstein R, Schall JI, Leonard MB, Zemel BS. Effect of high-dose cholecalciferol (vitamin D(3)) on bone and body composition in children and young adults with HIV infection: a randomized, double-blind, placebo-controlled trial. Osteoporos Int. 2017 Jan;28(1):201-209. doi: 10.1007/s00198-016-3826-x. Epub 2016 Nov 11.

Brown JC, Schall JI, Rutstein RM, Leonard MB, Zemel BS, Stallings VA. The impact of vitamin D3 supplementation on muscle function among HIV-infected children and young adults: a randomized controlled trial. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):145-53.


Responsible Party:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT01475890 History of Changes
Other Study ID Numbers:	11-008093 5R01AT005531-02 ( U.S. NIH Grant/Contract )
First Posted:	November 22, 2011 Key Record Dates
Last Update Posted:	March 17, 2017
Last Verified:	March 2017

Keywords provided by Children's Hospital of Philadelphia:


HIV/AIDS Nutrition

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Vitamins Vitamin D Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

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