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

Arm | Intervention/treatment |
---|---|
Active Comparator: 7000IU/day
29 subjects will be randomized to receive 7000IU/day of vitamin D3.
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Dietary Supplement: Vitamin D3
7000IU per day of vitamin D3 for 12 months.
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Placebo Comparator: Placebo
29 subjects will be randomized to receive placebo.
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Dietary Supplement: Placebo
Once a day for 12 months.
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- Vitamin D Supplementation Safety [ Time Frame: 12 months ]elevated serum calcium (above age-specific range) associated with elevated serum 25D (>160 ng/mL)

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

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
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Virginia A Stallings, MD | Children's Hospital of Philadelphia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |