Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among HIV-infected Children and Adolescents (CAL-D)
Adverse Bone Health, HIV Infection
About this trial
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
Eligibility Criteria
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.
Sites / Locations
- HIV-NAT, Thai Red Cross - AIDS Research Centre
- Queen Sirikit National Institute of Child Health
- Faculty of Medicine and Research Institute for Health Sciences (RIHES), Chiang Mai University
- Nakornping hospital (NKP)
- Chiangrai Prachanukroh Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
High dose vitamin D and calcium
Normal dose vitamin D and calcium
Fixed-dose combination (FDC) of 1,500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3, administered orally twice daily plus vitamin D2 (20,000 IU/cap) administered once weekly (a total of 1,200 mg of elemental calcium and 3,200 IU of vitamin D daily)
Fixed-dose combination (FDC) of 1,500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3, administered orally twice daily (a total of 1,200 mg of elemental calcium and 400 IU of vitamin D daily)