VITALITY: Vitamin D for adolescents with HIV to reduce musculoskeletal morbidity and immunopathology - Baseline Data – User Guide

Persistent identifier

10.17037/DATA.00003868

Description

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.

Data collection methods

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.

Geographic regions

Greater Harare, Zimbabwe

Key dates

Population

842 children aged 11-19 years with perinatally-acquired HIV who are resident in greater Harare

Ethics

Organisation Ethics ID Other information
Biomedical Research Ethics Committee University of Zambia 1116-2020  
London School of Hygiene & Tropical Medicine 22030  

Keywords

HIV, Bone and mineral metabolism, Adolescence, Puberty, Zimbabwe

Language of written material

English

Project information

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

Creators

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

Associated roles

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

File description

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)