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

Keren Middelkoop, Justine Stewart, Neil Walker, Carmen Delport, David A. Jolliffe, Anna K. Coussens, James Nuttall, Jonathan C. Y. Tang, William D. Fraser, Christopher J. Griffiths, Geeta Trilok Kumar, Suzanne Filteau, Richard L. Hooper, Robert J. Wilkinson, Linda-Gail Bekker, Adrian R. Martineau (Lead Author)

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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.

Original languageEnglish
Pages (from-to)63-70
Number of pages8
JournalInternational Journal of Infectious Diseases
Volume134
Early online date20 May 2023
DOIs
Publication statusPublished - Sep 2023

Keywords

  • Interferon-gamma release assay
  • Randomized controlled trial
  • Tuberculosis
  • Vitamin D

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