VITamin D for AdoLescents with HIV to reduce musculoskeletal morbidity and ImmunopaThologY (VITALITY): an individually randomised, double-blinded placebo-controlled trial

Funder: The European & Developing Countries Clinical Trials Partnership (EDCTP)

Amount: €3,943,983

PI: Prof Rashida Ferrand (LSHTM/ Biomedical Research & Training Institute (BRTI), Harare)

Co-applicants:

Dr Celia Gregson (Bristol)

Prof Helen Weiss (LSHTM)

Prof Suzanne Filteau (LSHTM)

Prof Sarah Rowland-Jones (Oxford)

Dr Louis Marie Yindom (Oxford)

Dr Lackson Kasonka (Zambia)

Dr Hilda Mujuru (Zimbabwe)

Dr Katharina Kranzer (LSHTM)

Prof Ulrich Schaible (Germany)

Dr Grace McHugh (BRTI)

Dr Ruramayi Rukuni (BRTI)

Dr Victoria Simms (LSHTM)

Dates: 2020-2025

Summary

We will conduct a trial to evaluate the efficacy of high-dose vitamin D₃ plus calcium carbonate in improving the musculoskeletal health of children living with HIV infection in sub-Saharan Africa.

The objectives are to investigate the effect of the intervention on:

i)                    bone density (adjusting for body size)
ii)                   bone turnover
iii)                 muscle mass and strength
iv)                 immune regulation

The trial will be conducted in two countries with high HIV prevalence, Zimbabwe and Zambia, in partnership with institutions from the UK and Germany. We will randomise 800 children living with HIV aged 8 to 16 years taking ART to intervention or placebo for one year, with further follow-up for another year to investigate sustainability of the intervention effect.‌