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

Phase 3

Completed

• Conditions: HIV Infection; Adverse Bone Health
• Interventions: Dietary Supplement: High dose vitamin D and calcium; Dietary Supplement: Normal dose vitamin D and calcium

• Registration Number: NCT02426840
• Lead Sponsor: Chiang Mai University

Brief 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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose vitamin D and calcium	High 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)
Normal 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 (a total of 1,200 mg of elemental calcium and 400 IU of vitamin D daily)

Primary Outcome Measures

Name	Time	Method
lumbar spine Bone Mineral Density (BMD)	48 weeks	To compare the changes in lumbar spine BMD in perinatally HIV-infected children and adolescents receives 48-week of calcium and high-dose vitamin D supplementation with that of children and adolescents receiving 48-week of calcium and normal dose vitamin D supplementation.

Trial Locations

Locations (5)

Nakornping hospital (NKP); 🇹🇭 Chiang Mai, Thailand

Chiangrai Prachanukroh Hospital; 🇹🇭 Chiang Rai, Thailand

HIV-NAT, Thai Red Cross - AIDS Research Centre; 🇹🇭 Bangkok, Thailand

Faculty of Medicine and Research Institute for Health Sciences (RIHES), Chiang Mai University; 🇹🇭 Chiang Mai, Thailand

Queen Sirikit National Institute of Child Health; 🇹🇭 Bangkok, Thailand