NCT02426840

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

Effect of Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among Perinatally HIV-infected Children and Adolescents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 10 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

Since there is no cure for HIV, therefore antiretroviral therapy must be taken life-long. Some of the HIV medications can negatively impact the health of the bone and is even more exacerbated in perinatally HIV-injected children and adolescents because this is the period when the bone peaks. Bone loss during this period can be devastating and increase the risk for developing weak bones later in life. Supplementation of calcium and vitamin D have not been well studied in HIV-infected children and adolescents in developing countries. Therefore it is not clear whether higher doses of these supplementations can thwart the damages or not.

Detailed description

Adverse bone health is one of the major long-term complications among perinatally HIV-infected children and adolescents receiving ART. Since a great deal of bone mineral accrual occurs during the adolescent years and the peak attainment is usually seen at age 18 years, the loss of bone deposition during this period could lead to serious consequences, particularly increased risk of osteoporosis and bone fragility in later of life. A previous study demonstrated that prevalence of low BMD among perinatally HIV-infected Thai children and adolescents was high (25%). However, the prevention strategies such as calcium and vitamin D supplementation which are widely recommended by many guidelines for preventing of osteoporosis and bone fracture have not been well studied to prove their effectiveness among HIV-infected children and adolescents, especially in resource-limited countries. This is considered as the critical research question in pediatric HIV/AIDS field which are urgently required robust and in-depth investigations. This randomized clinical trial study will provide important information about the effect of calcium and high dose (comparing to normal dose) vitamin D supplementation on BMD among ART-experienced, perinatally acquired HIV-infected children and adolescents to best understand the relative contributions of the supplementation to improve bone health status. This study will address research questions, fill gaps in knowledge, and draw clinician attentions to the important long-term medical complications in children and adolescents who are growing up with HIV. Moreover, this study will inform healthcare providers and policy makers about the importance of calcium and vitamin D supplementation as one of the measurement to prevent long-term deterioration of bone mass and the mean to promote bone health among these populations. The funding for this study is the National Research University, Chiang Mai University.

Conditions

• Adverse Bone Health
• HIV Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High dose vitamin D and calcium	participants will receive a FDC tablet containing 1500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3. This drug will be administered as 1 tablet orally twice daily and is to be taken with food. In addition, participants will receive vitamin D2 capsule containing 20,000 IU of ergocalciferol, which will be administered as 1 capsule orally once weekly at any time (not related with meal).
DIETARY_SUPPLEMENT	Normal dose vitamin D and calcium	participants will receive a FDC tablet containing 1500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3. This drug will be administered as 1 tablet orally twice daily and is to be taken with food

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2015-04-27
• Last updated: 2019-08-08

Locations

5 sites across 1 country: Thailand