Randomized Phase III Trial Comparing Conventional Vitamin D Supplementation vs. Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients Treated by Neoadjuvant or Adjuvant Chemotherapy.
Randomized Phase III Trial Comparing Conventional Vitamin D Supplementation vs. Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients Treated by Neoadjuvant or Adjuvant Chemotherapy.
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.
Inclusion Criteria:
Complementary inclusion criterion for randomization
- Proved vitamin D deficiency as defined by serum vitamin D level lower than 30 ng/ml (75 nmol/L).
Exclusion Criteria:
traités dans les 5 ans précédents.
Contraindication to calcium or cholecalciferol
Known severe hypersensitivity to vitamin D or to calcium supplementation or to one of the excipients.
Disease and/or medical conditions accompanied by hypercalcaemia and/or hypercalciuria
Calcium lithiasis and tissue calcification
Hypervitaminosis D
Presence of significant comorbidities:
i) Uncontrolled endocrine disease ii) Known disorders of calcium phophorus laboratory testing iii) Proved osteopenia or osteoporosis requiring vitamin D and calcium supplements
Concomitant treatment with other experimental products or another vitamin D calcium treatment
Pregnancy, breastfeeding or of reproductive potential not using an effective contraceptive method
Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature