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
Journal: International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 2023;134():63-70
PMID: 37211272
OBJECTIVES
To determine whether weekly oral supplementation with 10,000 IU vitamin D 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 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 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.
Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
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