Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients

Phase 3 Completed 215 enrolled Institut du Cancer de Montpellier - Val d'Aurelle

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare normalization of vitamin D serum level after 6 months of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional vitamin D supplementation.

Timeline

Start: 2011-07
Primary completion: 2014-12
Completion: 2014-12

Outcome

Met primary endpoint

paper At 6 months, more patients presented with a normalized vitD level in the T arm (30% versus 12.6%; P = 0.003). PMID 27029707 ↗

Publications

Results Jacot W, Firmin N, Roca L, Topart D, Gallet S, Durigova A, Mirr S, Abach L, Pouderoux S, D'Hondt V, Bleuse JP, Lamy PJ, Romieu G. Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study. Ann Oncol. 2016 Jul;27(7):1235-41. doi: 10.1093/annonc/mdw145. Epub 2016 Mar 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cholecalciferol	Other / unclassified	200 iu	Oral
Subject	Cholecalciferol	Other / unclassified	100000 iu	Oral
Background	Calcium	Small molecule	500 mg	Oral