Vitamin D Supplementation in HIV Youth
This trial is active, not recruiting.
|Phase||phase 2/phase 3|
|Sponsor||University Hospital Case Medical Center|
|Start date||December 2011|
|End date||December 2016|
|Trial size||180 participants|
|Trial identifier||NCT01523496, 09-11-06|
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Vitamin D levels
time frame: 24 months
Impact of Vitamin D levels on surrogate markers of CVD
time frame: 6, 12 and 24 months
Male or female participants from 8 years up to 25 years old.
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
|Official title||Vitamin D Supplementation and HIV-related Complications in Children and Young Adults|
|Principal investigator||Grace McComsey, MD, FIDSA|
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