Vitamin D Supplementation in HIV Youth
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ClinicalTrials.gov Identifier: NCT01523496 |
Recruitment Status :
Completed
First Posted : February 1, 2012
Results First Posted : February 6, 2018
Last Update Posted : March 8, 2018
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections | Drug: Vitamin D control dose Drug: Vitamin D supplementation- | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 190 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Vitamin D Supplementation and HIV-related Complications in Children and Young Adults |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: HIV + Young Adults
All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)
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Drug: Vitamin D control dose
18,000 IU per month
Other Name: 25(OH)D3 low dose Drug: Vitamin D supplementation- 60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
Other Name: 25(OH)D3 medium dose or 25(OH)high dose |
Active Comparator: HIV - Controls
HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)
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Drug: Vitamin D control dose
18,000 IU per month
Other Name: 25(OH)D3 low dose Drug: Vitamin D supplementation- 60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
Other Name: 25(OH)D3 medium dose or 25(OH)high dose |
- Changes in Serum 25(OH)D3 Levels [ Time Frame: 6 months ]Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )
- Changes in Vitamin D Binding Protein (VDBP) [ Time Frame: 6 months ]Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.

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Ages Eligible for Study: | 8 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Ages 8-25
- Documented HIV-1 infection
- On stable antiretroviral therapy for > 3 months
- Cumulative antiretroviral therapy of at least 6 months
- 25(OH)D level < 30 ng/ml at screening
Exclusion Criteria:
- > 400 IU daily regular vitamin D intake
- Parathyroid/calcium disorders
- Active malignancy
- Pregnancy/intent to become pregnant/breastfeeding
- Chronic infectious/inflammatory conditions
- Creatinine clearance < 50 ml/min
- Hemoglobin < 9.0 g/dL
- Aspartate aminotransferase and alanine aminotransferase > 2.5 upper limit of normal
- Diabetes requiring hypoglycemic agents
- Known coronary artery disease
- Inability to swallow pills

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): NCT01523496
United States, Georgia | |
Emory Children's Center | |
Atlanta, Georgia, United States, 30322 | |
United States, Ohio | |
University Hospitals Case Medical Center | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Grace McComsey, MD, FIDSA | University Hospitals Cleveland Medical Center |
Responsible Party: | Grace McComsey, Professor of Pediatrics and Medicine, Chief Pediatric Infectious Diseases, Rheumatology and Global Health, University Hospitals Cleveland Medical Center |
ClinicalTrials.gov Identifier: | NCT01523496 |
Other Study ID Numbers: |
09-11-06 |
First Posted: | February 1, 2012 Key Record Dates |
Results First Posted: | February 6, 2018 |
Last Update Posted: | March 8, 2018 |
Last Verified: | February 2018 |
HIV Vitamin D Deficiency |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Vitamin D Ergocalciferols Cholecalciferol Calcifediol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |