Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among HIV-infected Children and Adolescents
Condition: Adverse Bone Health; HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): High dose vitamin D and calcium; Normal dose vitamin D and calcium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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).; 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
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adverse bone health; Bone demineralization; HIV-infection; Children; Adolescents; Calcium; Vitamin D; Supplementation