Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among HIV-infected Children and Adolescents (CAL-D)

This is an interventional treatment trial for Adverse Bone Health focused on measuring Adverse bone health, Bone demineralization, HIV-infection, Children, Adolescents, Calcium, Vitamin D, Supplementation Read More

Inclusion criteria:

• Participants age 10-20 years.
• Have a history and/or medical record of HIV infection.
• Have a history and/or medical record and/or maternal HIV status confirmed of perinatally acquired HIV infection.
• Have virological suppression after receiving ART, defined as plasma HIV RNA less than 400 copies/mL within 12 months prior to screening.
• Participants who had been evaluated for BMD (have BMD result) within 1 year prior to entry visit.
• Caregivers and/or participants gives written inform consent/assent form.

Exclusion criteria:

• Participants who have a documented history of bone fracture at any time prior to screening.
• Participants who have received any form of calcium greater than 1000 mg/day of elemental calcium at least once within 6 months prior screening.
• Participants who have received any form of vitamin D (e.g., ergocalciferol or cholecalciferol) supplementation greater than 400 IU/day at least once within 6 months prior to screening.
• Participants who have received any past pharmacologic treatment for low bone density or osteoporosis (e.g., alendronate) at any time prior to screening.
• Participants who have a documented history of growth hormone deficiency at any time or using growth hormone within 6 months prior to screening.
• Participants who have a documented history of primary hyperparathyroidism, hypoparathyroidism, or cushing syndrome at any time prior to screening.
• Participants who have a documented prior history of kidney stone, renal failure, or renal function impairment (serum creatinine >2 mg/dL).
• Participants who have a documented prior history of chronic active liver diseases, or liver impairment (alanine aminotransferase [ALT] >100 IU/L at least 2 times within 6 months).
• Participants who have a documented prior history of thalassemia major (homozygous β-Thalassemia or β-Thalassemia/Hemoglobin E) or sickle cell disease.
• Participants use any oral, intravenous, or inhaled steroids within 6 months prior to study entry (intranasal steroid use is allowed).
• Participants who have received anticonvulsant medications (phenytoin, phenobarbital, carbamazepine), methotrexate, within 6 months prior to screening.
• Pregnancy or breast feeding
• Participants who have any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.