HIV/AIDS Musculoskeletal Diseases
Conditions
Interventions
Placebo
Vitamin D3 Calcium carbonate
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 11-19 years 2. Perinatally-acquired HIV infection 3. Taking ART for at least 6 months 4. A firm home address accessible for visiting and intending to remain there for 96 weeks 5. Willing to agree to participate in the study and to give samples of blood and rectal swabs 6. Defined care-giver able to provide informed consent for child to participate in trial (for those aged below 18 years, unless emancipated minor) 7. HIV status disclosed to participant for those aged older than 12 years (13-19 years)
Exclusion criteria
Exclusion criteria: 1. Any condition (except HIV) that may prove fatal during the study period (e.g. malignancy, end-stage HIV disease or other conditions deemed likely fatal by the trial physician) 2. Taking TB treatment 3. Pregnant or breast-feeding 4. Condition likely to lead to lack of understanding of study procedures or to uncooperative behaviour e.g. neurocognitive disease, developmental delay or psychiatric illness 5. History of thyrotoxicosis, kidney stones, lymphoma 6. History of chronic renal disease 7. History of hypercalcemia 8. History of a disorder of phosphate metabolism 9. Physical or radiological (if available) signs of rickets 10. History of osteomalacia 11. Living in the same household as a trial participant (to avoid inadvertent mix-up of trial drugs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DXA measured total body less-head bone mineral density Z-score (TBLH-BMD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lumbar spine bone mineral apparent density Z-score ;Lean muscle mass (kg) ;Grip strength (kg) ;No. of respiratory tract infections ;TBLH-BMD Z-score adjusted for height | — |
Countries
Zambia, Zimbabwe
Contacts
Public ContactAnna Shepherd
Communications Officer
Outcome results
None listed