Vitamin D Supplementation in HIV Youth
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospitals Cleveland Medical Center
Collaborator:
Emory University
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01523496
First received: January 27, 2012
Last updated: January 28, 2016
Last verified: January 2016
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Purpose
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV+ |
Drug: Vitamin D3 |
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: | Vitamin D Supplementation and HIV-related Complications in Children and Young Adults |
Resource links provided by NLM:
Further study details as provided by University Hospitals Cleveland Medical Center:
Primary Outcome Measures:
- Vitamin D levels [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Evaluate the dose-related efficacy of correction of Vitamin D deficiency for improving 25(OH)D levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of 3 different dosing regimens of oral Vitamin D supplementation.
Secondary Outcome Measures:
- Impact of Vitamin D levels on surrogate markers of CVD [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]Evaluate the dose-related efficacy of correction of vitamin D deficiency for improving surrogate markers (Pulse wave velocity, Carotid IMT)of CVD in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of 3 different dosing regimens of oral vitamin D supplementation.
| Estimated Enrollment: | 180 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: HIV + Young Adults
All will be HIV+ and receiving randomized dose of vitamin D3
|
Drug: Vitamin D3
Vitamin D3, randomized to receive either 18,000 IU per month, 60,000 IU per month or 120,000 IU per month
Drug: Vitamin D3
Vitamin D3 18,000IU/month; 60,000IU/month; 120,000IU/month
|
|
Active Comparator: HIV - Controls
HIV negative controls randomized to one of 3 doses of Vitamin D3
|
Drug: Vitamin D3
Vitamin D3, randomized to receive either 18,000 IU per month, 60,000 IU per month or 120,000 IU per month
Drug: Vitamin D3
Vitamin D3 18,000IU/month; 60,000IU/month; 120,000IU/month
|
Eligibility| Ages Eligible for Study: | 8 Years to 25 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Ages 8-25
- Documented HIV-1 infection
- On stable ART for > 3 months
- Cumulative ART 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
- AST and ALT > 2.5 ULN
- Diabetes requiring hypoglycemic agents
- Known coronary artery disease
- Inability to swallow pills
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523496
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523496
Locations
| 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 | |
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Emory University
Investigators
| Principal Investigator: | Grace McComsey, MD, FIDSA | University Hospitals Cleveland Medical Center |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Grace McComsey, Professor of Pediatrics and Medicine, Chief Pediatric Infectious Diseases, Rheumatology and Global Health, University Hospital Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT01523496 History of Changes |
| Other Study ID Numbers: | 09-11-06 |
| Study First Received: | January 27, 2012 |
| Last Updated: | January 28, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University Hospitals Cleveland Medical Center:
|
HIV+ Vitamin D Deficiency |
Additional relevant MeSH terms:
|
Vitamins Cholecalciferol Vitamin D Ergocalciferols |
Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 26, 2016