Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicentre phase 3 double-blind randomised placebo-controlled trial (ViDiKids)
- Author(s)
- Middelkoop, K; Stewart, J; Walker, N; Delport, C; Jolliffe, DA; Coussens, AK; Nuttall, J; Tang, JCY; Fraser, WD; Griffiths, CJ; Kumar, GT; Filteau, S; Hooper, RL; Wilkinson, RJ; Bekker, LG; Martineau, AR;
- Journal Title
- International Journal for Infectious Diseases
- Abstract
- BACKGROUND: Vitamin D metabolites induce innate antimycobacterial responses in vitro. Observational studies consistently report independent associations between vitamin D deficiency and increased susceptibility to Mycobacterium tuberculosis infection. METHODS: We conducted a randomised placebo-controlled trial to determine whether weekly oral supplementation with 10,000 IU vitamin D(3) for 3 years reduced risk of sensitisation to M. tuberculosis in Cape Town schoolchildren aged 6-11 years with negative QuantiFERON-TB Gold Plus (QFT-Plus) assay results at baseline. The primary outcome was a positive end-trial QFT-Plus result, analysed using a mixed effects logistic regression model with school of attendance included as a random effect. RESULTS: 1682 children attending 23 schools were randomised (829 to vitamin D, 853 to placebo). Mean end-study 25(OH)D concentrations in participants randomised to vitamin D vs. placebo were 104.3 vs. 64.7 nmol/L, respectively (95% CI for difference, 37.6 to 41.9 nmol/L). 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% CI 0.62 to 1.19, P=0.35). CONCLUSIONS: Weekly oral supplementation with 10,000 IU vitamin D(3) for 3 years elevated serum 25(OH)D concentrations among Cape Town schoolchildren but did not reduce their risk of QFT-Plus conversion.
- Publisher
- Elsevier
- Keywords
- Vitamin D; interferon-gamma release assay; randomised controlled trial; tuberculosis
- Research Division(s)
- Infectious Diseases And Immune Defence
- PubMed ID
- 37211272
- Publisher's Version
- https://doi.org/10.1016/j.ijid.2023.05.010
- Open Access at Publisher's Site
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Creation Date: 2023-06-15 02:03:52
Last Modified: 2023-06-15 02:34:49