Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicentre phase 3 double-blind randomised placebo-controlled trial (ViDiKids)

Middelkoop, Keren, Stewart, Justine, Walker, Neil, Delport, Carmen, Jolliffe, David A., Coussens, Anna K., Nuttall, James, Tang, Jonathan C. Y. ORCID: https://orcid.org/0000-0001-6305-6333, Fraser, William D., Griffiths, Christopher J., Kumar, Geeta Trilok, Filteau, Suzanne, Hooper, Richard L., Wilkinson, Robert J., Bekker, Linda-Gail and Martineau, Adrian R. (2023) Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicentre phase 3 double-blind randomised placebo-controlled trial (ViDiKids). International Journal of Infectious Diseases, 134. pp. 63-70. ISSN 1201-9712

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Abstract

Objectives: To determine whether weekly oral supplementation with 10,000 IU vitamin D 3 for 3 years reduces the risk of sensitization to M. tuberculosis in South African schoolchildren aged 6-11 years with negative QuantiFERON-tuberculosis (TB) Gold Plus (QFT-Plus) assay results at baseline. Methods: We conducted a phase 3 randomized placebo-controlled trial in 1682 children attending 23 primary schools in Cape Town. The primary outcome was a positive end-trial QFT-Plus result, analyzed using a mixed effects logistic regression model with the school of attendance included as a random effect. Results: 829 vs. 853 QFT-Plus-negative children were randomized to receive vitamin D 3 vs. placebo, respectively. Mean end-study 25(OH)D concentrations in participants randomized to vitamin D vs. placebo were 104.3 vs 64.7 nmol/l, respectively (95% confidence interval for difference, 37.6 to 41.9 nmol/l). A total of 76/667 (11.4%) participants allocated to vitamin D vs. 89/687 (13.0%) participants allocated to placebo tested QFT-Plus positive at 3-year follow-up (adjusted odds ratio 0.86, 95% confidence interval 0.62-1.19, P = 0.35). Conclusion: Weekly oral supplementation with 10,000 IU vitamin D 3 for 3 years elevated serum 25(OH)D concentrations among QFT-Plus-negative Cape Town schoolchildren but did not reduce their risk of QFT-Plus conversion.

Item Type: Article
Additional Information: Funding information: This research was funded by the UK Medical Research Council (refs MR/R023050/1 and MR/M026639/1, both awarded to ARM). RJW was supported by Wellcome (104803, 203135). He also received support from the Francis Crick Institute which is funded by Cancer Research UK (FC2112), the UK Medical Research Council (FC2112) and Wellcome (FC2112). For the purposes of open access the author has applied a CC-BY public copyright to any author-accepted manuscript arising from this submission.
Uncontrolled Keywords: interferon-gamma release assay,randomized controlled trial,tuberculosis,vitamin d,microbiology (medical),infectious diseases,sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2726
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Musculoskeletal Medicine
Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health
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Depositing User: LivePure Connector
Date Deposited: 17 May 2023 15:30
Last Modified: 19 Oct 2023 03:36
URI: https://ueaeprints.uea.ac.uk/id/eprint/92085
DOI: 10.1016/j.ijid.2023.05.010

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