10.17037/DATA.00003868
The VITamin D for AdoLescents with HIV to reduce musculoskeletal morbidity and ImmunopaThologY (VITALITY) trial is a phase III two-site, individually randomised, double-blinded, placebo-controlled trial. Participants were randomised 1:1 to receive weekly vitamin D and daily 500mg calcium carbonate supplementation or placebo for 48 weeks. Participants were followed for a further 48 weeks to investigate the sustainability of intervention effect. 842 children aged 11-19 years with perinatally-acquired HIV resident in greater Harare (Zimbabwe site) or within Lusaka (Zambia site) were recruited. The baseline dataset contains information on the participants' living environment, health status, received treatments, exercise levels, and other information.
Participants completed a researcher-administered questionnaire on demographic and social characteristics and medical history, and a dietary assessment. They gave a blood sample for CD4 and HIV viral load tests (full blood count in Zambia). They had anthropometric measurements (height, sitting height and weight in both countries; waits, hip, calf, triceps circumfererence, skinfold thickness, Tanita bioimedance assessment Bodpod in Zambia). They had a total body and lumbar spine DXA scan. Those in Zimbabwe had a pQCT scan and a hand X-ray using the iDXA. A blood sample was taken for measurements of vitamin D pathway metabolites, bone turnover markers and iPTH, and for additional immunology studies in Zambia. 123 participants in each country had a rectal swab.
Greater Harare, Zimbabwe
842 children aged 11-19 years with perinatally-acquired HIV who are resident in greater Harare
Organisation | Ethics ID | Other information |
Biomedical Research Ethics Committee University of Zambia | 1116-2020 | |
London School of Hygiene & Tropical Medicine | 22030 |
HIV, Bone and mineral metabolism, Adolescence, Puberty, Zimbabwe
English
Project name | Funder/sponsor | Grant number |
VITamin D for AdoLescents with HIV to reduce musculoskeletal morbidity and ImmunopaThologY (VITALITY): an individually randomised, double-blinded placebo-controlled triaL | European and Developing Countries Clinical Trials Partnership | RIA2018CO-2512 |
Forename | Surname | Faculty / Dept | Institution | Role |
Victoria | Simms | London School of Hygiene & Tropical Medicine | Data Creator | |
Rashida | Ferrand | London School of Hygiene & Tropical Medicine | Data Creator |
Forename | Surname | Faculty / Dept | Institution | Role |
Tsitsi | Bandason | London School of Hygiene & Tropical Medicine | Data Manager | |
Suzanne | Filteau | London School of Hygiene & Tropical Medicine | Researcher |
Filename | Description | Access status | Licence |
VITALITY_baseline_data | VITALITY trial baseline dataset | Restricted | Data sharing agreement |
VITALITY_baseline_data_codebook | Codebook for VITALITY trial baseline dataset | Open | Creative Commons Attribution (CCBY) |
3868_UserGuide | User guide for VITALITY trial baseline dataset | Open | Creative Commons Attribution (CCBY) |