TB again not prevented by a small amount of Vitamin D – RCT

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

Int J Infect Dis. 2023 Sep;134:63-70. doi: 10.1016/j.ijid.2023.05.010

Keren Middelkoop 1, Justine Stewart 1, Neil Walker 2, Carmen Delport 3, David A Jolliffe 4, Anna K Coussens 5, James Nuttall 6, Jonathan C Y Tang 7, William D Fraser 7, Christopher J Griffiths 2, Geeta Trilok Kumar 8, Suzanne Filteau 9, Richard L Hooper 2, Robert J Wilkinson 10, Linda-Gail Bekker 3, Adrian R Martineau 11

Objectives: To determine whether weekly oral supplementation with 10,000 IU vitamin D3 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 D3 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 D3 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.

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