Power determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool

Abstract Thousands of observational studies have linked vitamin D deficiency with numerous diseases, but randomised controlled trials (RCTs) often fail to show benefit of supplementation. Population characteristics and trial design have long been suspected to undermine power but were not systematica...

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Autores principales:	Jason Wyse, Rebecca Mangan, Lina Zgaga
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/f1447639aae740ffbcac08cbd92a0e33
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spelling	oai:doaj.org-article:f1447639aae740ffbcac08cbd92a0e332021-12-02T14:49:11ZPower determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool10.1038/s41598-021-90019-72045-2322https://doaj.org/article/f1447639aae740ffbcac08cbd92a0e332021-05-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-90019-7https://doaj.org/toc/2045-2322Abstract Thousands of observational studies have linked vitamin D deficiency with numerous diseases, but randomised controlled trials (RCTs) often fail to show benefit of supplementation. 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 15–60 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.Jason WyseRebecca ManganLina ZgagaNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Jason Wyse Rebecca Mangan Lina Zgaga Power determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool
description	Abstract Thousands of observational studies have linked vitamin D deficiency with numerous diseases, but randomised controlled trials (RCTs) often fail to show benefit of supplementation. 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 15–60 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.
format	article
author	Jason Wyse Rebecca Mangan Lina Zgaga
author_facet	Jason Wyse Rebecca Mangan Lina Zgaga
author_sort	Jason Wyse
title	Power determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool
title_short	Power determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool
title_full	Power determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool
title_fullStr	Power determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool
title_full_unstemmed	Power determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool
title_sort	power determination in vitamin d randomised control trials and characterising factors affecting it through a novel simulation-based tool
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/f1447639aae740ffbcac08cbd92a0e33
work_keys_str_mv	AT jasonwyse powerdeterminationinvitamindrandomisedcontroltrialsandcharacterisingfactorsaffectingitthroughanovelsimulationbasedtool AT rebeccamangan powerdeterminationinvitamindrandomisedcontroltrialsandcharacterisingfactorsaffectingitthroughanovelsimulationbasedtool AT linazgaga powerdeterminationinvitamindrandomisedcontroltrialsandcharacterisingfactorsaffectingitthroughanovelsimulationbasedtool
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Power determination in vitamin D randomised control trials and characterising factors affecting it through a novel simulation-based tool

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