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Population characteristics and trial design have long been suspected to undermine power but were not systematically investigated. We propose a flexible generative model to characterise benefit of vitamin D supplementation at the individual level, and use this to quantify power in RCTs. The model can account for seasonality and population heterogeneity. In a simulated 1-year trial with 1000 participants per arm and assuming a 25-hydroxyvitamin D (25OHD) increase of 20 nmol\/L due to the intervention, with baseline 25OHD in the population of 15, 35, 50, 60 and 75 nmol\/L, the power to detect intervention effect was 77%, 99%, 95%, 68% and 19%, respectively. The number of participants required per arm to achieve 80% power according to baseline 25OHD of 15\u201360 nmol\/L was 1200, 400, 600 and 1400, respectively. As expected, larger increases in 25OHD due to supplementation improved power in certain scenarios. For a population baseline of 50 nmol\/L, with 1500 participants in each arm, there was 100% power to detect a 20 nmol\/L 25OHD increase while it was 76% for a 10 nmol\/L increase. Population characteristics and trial design, including temporal considerations, have a dramatic impact on power and required sample size in vitamin D RCTs.<\/jats:p>","DOI":"10.1038\/s41598-021-90019-7","type":"journal-article","created":{"date-parts":[[2021,5,24]],"date-time":"2021-05-24T10:02:53Z","timestamp":1621850573000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Power determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool"],"prefix":"10.1038","volume":"11","author":[{"given":"Jason","family":"Wyse","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rebecca","family":"Mangan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lina","family":"Zgaga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,5,24]]},"reference":[{"key":"90019_CR1","doi-asserted-by":"publisher","first-page":"2035","DOI":"10.1136\/bmj.g2035","volume":"348","author":"E Theodoratou","year":"2014","unstructured":"Theodoratou, E., Tzoulaki, I., Zgaga, L. & Ioannidis, J. 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