Vitamin D Supplementation in HIV
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-infection/Aids |
Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Safe and Effective Vitamin D Supplementation in HIV |
- Vitamin D Supplementation Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]elevated serum calcium (above age-specific range) associated with elevated serum 25D (>160 ng/mL)
| Enrollment: | 58 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | January 2017 |
| Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 24 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
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 |
| Study First Received: | September 13, 2011 |
| Last Updated: | March 15, 2016 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 23, 2016