Status:
COMPLETED
Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 suppleme...
Eligibility Criteria
Inclusion
- Breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 months prior to study enrollment
- WHO performance status 0-1
- Age ≥18 years old
- Affiliation to a social security regime or beneficiary of equivalent social protection
- Written informed consent provided before any study specific procedures
- 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
- Metastatic disease
- History or presence of any other malignancy (except curatively treated nonmelanoma skin cancer or in situ cervix carcinoma) ………….
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT01480869
Start Date
July 1 2011
End Date
December 1 2014
Last Update
September 10 2019
Active Locations (1)
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1
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, France, 34298