NIH

There is increasing evidence that HIV disease, or its treatment, may lead to reduced bone mass. Osteopenia and osteoporosis are common in adults with HIV. Children with HIV have reduced rates of bone mineral gain. These effects are potentially very significant as failure to gain bone mass in childhood leads to reduced peak bone mineral mass, and significantly increases the life-long risk of osteoporosis and fractures.

The causes of reduced bone mass in HIV disease appaers to be multifactorial. Bone turnover in increased, especially bone resorption.

Possible interventions to reverse the HIV associated deficit in bone mineralization include

• calcium supplementation, which is extremely safe and has been shown to reduce bone resorption (one likely cause of low bone mineral mass) in children
• vitamin D, which is required for calcium absorption and is intake and serum levels are often low in children

Although it is believed that children with HIV have poor rates of bone mineral accretion, children with HIV are not routinely screened for low bone mineral density as there is no proven therapy to reverse this. As part of standard care, dietary advice (to eat adequate amounts of calcium etc) can be given, but the use of additional calcium and vitamin D supplements can not be routinely recommended as it remains unproven. The objective of this study is to test a simple low-cost intervention, and assess its effects on bone mineral accretion in children with HIV/AIDS.

The purpose of this study is to carry out a randomized blinded placebo controlled trial of calcium (100mg/d) and vitamin D (1000 IU/d) supplementation in HIV positive children.

Other

There are no risks associated with the stable isotopes. There is a small risk of bruising, bleeding or infection associated with the blood draws and insertion of the iv catheter. These will be minimized by having only experienced people carry out these procedures. The doses of calcium and vitamin D proposed are safe. Only children with a usual calcium intake less that 800 IU/d will be recruited to ensure that the total vitamin D intake dose not exceed the Institute of Medicine's tolerable upper limit for vitamin D intake of 2000 IU/d.

There are no specific benefits to subjects.