Randomized controlled trials of vitamin D and cancer incidence: A modeling study.
TLDR
A model is developed for use in designing and analyzing vitamin D RCTs with application to cancer incidence with good agreement between the model estimates and reported hazard ratios.Abstract:
Although geographic ecological studies and observational studies find that ultraviolet B exposure and 25-hydroxyvitamin D [25(OH)D] concentrations are inversely correlated with 15-20 types of cancer, few randomized controlled trials (RCTs) of vitamin D support those findings. The poor design of some RCTs may account for that lack of support. Most vitamin D RCTs to date have considered the vitamin D dose, rather than initial, final, or changes in, serum 25(OH)D concentrations. Here a model is developed for use in designing and analyzing vitamin D RCTs with application to cancer incidence. The input variables of the model are vitamin D dose, baseline and achieved 25(OH)D concentrations, known rates of cancer for the population, and numbers of participants for the treatment and placebo arms is estimated-vitamin D dosage and numbers of participants are varied to achieve desired hazard ratio significance, using information from two vitamin D RCTs on cancer incidence conducted in Nebraska with good agreement between the model estimates and reported hazard ratios. Further improvements to the conduct of vitamin D RCTs would be to start the trial with a moderate bolus dose to achieve the desired 25(OH)D concentrations, and bloodspot 25(OH)D assay use in summer and winter annually to monitor seasonal and long-term changes in 25(OH)D concentration and compliance, and to allow dosage adjustment for achievement of desired vitamin D status.read more
Citations
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Non-skeletal health effects of vitamin D supplementation: A systematic review on findings from meta-analyses summarizing trial data.
Lars Rejnmark,Lise Sofie Bislev,Kevin D. Cashman,Gudny Eiriksdottir,Martin Gaksch,Martin R. Grübler,Martin R. Grübler,Guri Grimnes,Vilmundur Gudnason,Paul Lips,Stefan Pilz,Natasja M. van Schoor,Mairead Kiely,Rolf Jorde +13 more
TL;DR: The fact that most MAs on results from RCTs did not show a beneficial effect does not disprove the hypothesis suggested by observational findings on adverse health outcomes of low 25OHD levels.
Journal ArticleDOI
Vitamin D testing and treatment: a narrative review of current evidence.
Stefan Pilz,Armin Zittermann,Christian Trummer,Verena Theiler-Schwetz,Elisabeth Lerchbaum,Martin H Keppel,Martin R. Grübler,Winfried März,Winfried März,Winfried März,Marlene Pandis +10 more
TL;DR: An update on vitamin D guidelines and the current evidence on the role of vitamin D for human health with its subsequent implications for patient care and public health issues is provided.
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Vitamin D Supplementation Guidelines for General Population and Groups at Risk of Vitamin D Deficiency in Poland-Recommendations of the Polish Society of Pediatric Endocrinology and Diabetes and the Expert Panel With Participation of National Specialist Consultants and Representatives of Scientific Societies-2018 Update.
Agnieszka Rusińska,Paweł Płudowski,Mieczysław Walczak,Maria Katarzyna Borszewska-Kornacka,Artur Bossowski,Danuta Chlebna-Sokół,Justyna Czech-Kowalska,Anna Dobrzańska,Edward Franek,Ewa Helwich,Teresa Jackowska,Maria Kalina,Jerzy Konstantynowicz,Janusz Książyk,Andrzej Lewiński,Jacek Łukaszkiewicz,Ewa Marcinowska-Suchowierska,Artur Mazur,Izabela Michałus,Jarosław Peregud-Pogorzelski,Hanna Romanowska,Marek Ruchała,Piotr Socha,Mieczysław Szalecki,Mirosław Wielgoś,Danuta Zwolińska,Arkadiusz Zygmunt +26 more
TL;DR: In this article, the authors provide health care professionals in Poland an updated set of recommendations for the prevention, diagnosis, and treatment of vitamin D deficiency using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system.
Journal ArticleDOI
Why vitamin D clinical trials should be based on 25-hydroxyvitamin D concentrations.
TL;DR: A hybrid observational approach to vitamin D RCT design is proposed, requiring an understanding of serum 25(OH)D concentration-health outcome relationships, and measuring baseline 25( OH)D values, recruiting non-replete subjects, measuring serum 25-OH-D during the trial for adjustment of supplemental doses for achievement of pretrial selection of target 25-hydroxyvitamin D values.
Journal ArticleDOI
Vitamin D and Breast Cancer: Latest Evidence and Future Steps:
Manar Atoum,Foad Alzoughool +1 more
TL;DR: An association between serum vitamin D concentration and breast cancer risk is reflected, the link between vitamin D receptor genetic polymorphisms and breastcancer risk is revealed, and the relationship between vitaminD level, breast cancerrisk, and prognostic factors such as tumor stage, grade, size, lymph node involvement, and hormone receptor status are reviewed.
References
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