Lead Researcher(s)

Rashida Ferrand

Funder(s)

European & Developing Countries Clinical Trials Partnership

Partner(s)

University of Bristol, University Teaching Hospital of Zambia, Research Centre Borstel Leibniz Lung Center, University of Oxford, London School of Hygiene and Tropical Medicine, Sub-Saharan African Musculoskeletal Network, Ministry of Health and Child Care

Background

The VITALITY (VITamin D for AdoLescents with HIV to reduce musculoskeletal morbidity and ImmunopaThologY) study aims to address the bone deficits and pubertal delay associated with long-standing HIV in adolescents.

Study aim(s)

To establish whether supplementation with vitamin D and calcium optimizes musculoskeletal health among peripubertal children with HIV.

Study design

The VITALITY trial is a double-blind, placebo-controlled study conducted in Harare, Zimbabwe and Lusaka, Zambia. The objective is to determine the effect of a high dose of weekly vitamin D3 (20,000 IU) in combination with daily calcium carbonate (500 mg) or placebo over a period of 48 weeks. The primary outcome measure is bone density, assessed using dual-energy X-ray absorptiometry. The study enrolled 842 adolescents between the ages of 11 and 19 years who acquired HIV perinatally and have been on antiretroviral therapy (ART) for at least 6 months. The participants were randomly assigned to receive either the vitamin D and calcium supplementation or a placebo.

The findings of this study will contribute to understanding the impact of vitamin D and calcium supplementation on bone health in adolescents with HIV and may inform interventions to reduce musculoskeletal morbidity and immunopathology in this population.

Study dates

February 2020- June 2025