Vitamin D Dose Finding Study
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| ClinicalTrials.gov Identifier: NCT01092338 |
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Recruitment Status :
Completed
First Posted : March 24, 2010
Results First Posted : September 18, 2013
Last Update Posted : September 18, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections AIDS | Drug: Cholecalciferol (Vit D3) | Phase 2 |
The key role of vitamin D (vit D) in maintaining optimal bone health has long been recognized, but its role in modulating the innate immune response and inflammatory reaction has only recently come under active investigation. As such, vit D is an increasingly frequently chosen and prescribed high dose dietary supplement,because it is thought to improve immune and inflammatory status in healthy people of all ages, and in those with chronic diseases including HIV/AIDS. Vit D also has calciotrophic functions essential for bone health, and poor vit D status contributes to the osteopenia/osteoporosis associated with antiretroviral therapy (ART). Vit D may improve insulin/glucose/lipid metabolism, blood pressure and risk of some cancers, all of which may complicate HIV/AIDS and its treatments. Poor vit D status is common in patients with HIV/AIDS of all ages and factors such as age, skin pigment, lactose intolerance and sun exposure alter the risks for vit D deficiency. In the multicenter U.S. REACH study of adolescents (72% African American), with and without HIV, showed that 87% had low serum 25D concentrations (<15 ng/mL), compared to 34% in a recent sample of healthy African American children from Philadelphia. Young African Americans are disproportionately affected by HIV infection in the US (~ 55% among persons with HIV aged 13 to 24 years are African American), and are also at high risk for vit D deficiency. Vit D therapy has great promise to improve major medical conditions and the quality of life for our patients with HIV/AIDS, yet the potential role of vit D in the treatment of HIV/AIDS has not been formally tested. Well-designed randomized trials are urgently needed to determine vit D supplementation safety and efficacy.
The investigators propose a two-phase study to establish safety and efficacy of high dose vit D supplementation in children and adults with HIV/AIDS. In Study Phase I, the safety and efficacy of two oral vit D3 doses (4000 and 7000 IU/d) are determined over 12 weeks in 44 subjects ages 5.0 to 24.9 y. The key safety measure is concurrently elevated serum calcium and 25D concentrations. Efficacy is evaluated by serum 25D concentration and cathelicidin (innate immune, antimicrobial protein) mRNA expression. Study Phase II is a 12 month, double blind, randomized, placebo controlled supplementation study (n=52). Key outcomes include safety and longterm 25D concentration within the goal range (32 to 160 ng/mL), improved cathelicidin mRNA expression, and measures of bone, muscle, inflammation, growth and body composition status, and HIV/AIDS disease severity. Based on the evidence and promise, vit D clearly deserves to be among the first nutrients evaluated in the National Center for Complimentary and Alternative Medicine (NCCAM) HIV research program.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 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 : | January 2010 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 4000IU
Subjects in this arm take a daily dose of 4000IU of Vitamin D3
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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.
Other Names:
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Active Comparator: 7000IU
Subjects in this arm of the study take a daily dose of 7000IU of Vitamin D3
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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.
Other Names:
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- Safety [ Time Frame: 12 weeks ]Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml).
- Efficacy of the Two Doses (4000 and 7000 IU/d) [ Time Frame: 12 weeks ]Daily D3 supplementation will result in 25D >= to 32/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 perinatally-acquired HIV/AIDS Group (PA subjects): 5.0 to 24.9 y
- Age for non-perinatally-acquired HIV/AIDS Group (non-PA subjects): 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)
- Subject and/or family commitment to the 3-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 D supplementation (subjects willing to discontinue supplementation will become eligible after a 2-month washout period)
- Baseline elevated serum calcium concentration
- 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): NCT01092338
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Virginia Stallings, MD | Children's Hospital of Philadelphia |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT01092338 History of Changes |
| Other Study ID Numbers: |
09-007332 R01AT005531 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 24, 2010 Key Record Dates |
| Results First Posted: | September 18, 2013 |
| Last Update Posted: | September 18, 2013 |
| Last Verified: | August 2013 |
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Human Immunodeficiency Virus Acquired Immune Deficiency Syndrome Vitamin D HIV Complementary therapies |
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Vitamin D |
Ergocalciferols Cholecalciferol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |