Vitamin D Supplementation in HIV Youth



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:8 - 25
Updated:4/17/2018
Start Date:December 2011
End Date:August 2016

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Vitamin D Supplementation and HIV-related Complications in Children and Young Adults

The purpose of this study is to determine the correct dose of Vitamin D to give to prevent
HIV related complications.

The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d)
to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d)
on HIV-related comorbidities including immune activation, inflammation, cardiovascular
diseases, and metabolic complications in HIV-infected youth.

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
We found this trial at
2
sites
Atlanta, Georgia 30322
1922
mi
from 91732
Atlanta, GA
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2033
mi
from 91732
Cleveland, OH
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