NCT01480869

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	calcium and cholecalciferol	Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid
DRUG	calcium and cholecalciferol	Tablet: calcium 500 mg bid + 2 ml drinkable solution cholecalciferol 100 000 IU whose schedule of administration depends on vitamin deficiency level: * 100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25-OHD level \< 10 ng/mL * 100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25-OHD level \< 20 ng/mL * 100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25-OHD level \< 30 ng/mL

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-11-29
• Last updated: 2026-03-12

Locations

1 site across 1 country: France