VITALITY Trial
- Conditions
- HIV/AIDSMusculoskeletal Diseases
- Registration Number
- PACTR202009897660297
- Lead Sponsor
- ondon School of Hygiene and Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 840
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)
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DXA measured total body less-head bone mineral density Z-score (TBLH-BMD) <br><br>
- Secondary Outcome Measures
Name Time Method umbar 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