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

Last updated: September 6, 2019
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Overall Status: Completed

Phase

3

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT01480869
VITACAL
VA 2010/12
2010-023459-27
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Breast adenocarcinoma treated by neoadjuvant or adjuvant chemotherapy within 12 monthsprior 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 (75nmol/L).

Exclusion

Exclusion Criteria:

  • Metastatic disease

  • History or presence of any other malignancy (except curatively treated nonmelanomaskin 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 ofthe 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 laboratorytesting iii) Proved osteopenia or osteoporosis requiring vitamin D and calciumsupplements

  • Concomitant treatment with other experimental products or another vitamin D calciumtreatment

  • Pregnancy, breastfeeding or of reproductive potential not using an effectivecontraceptive method

  • Legal inability or restricted legal ability. Medical or psychological conditions notallowing proper study completion or informed consent signature

Study Design

Total Participants: 215
Study Start date:
July 01, 2011
Estimated Completion Date:
December 31, 2014

Connect with a study center

  • CRLC Val d'Aurelle-Paul Lamarque

    Montpellier, 34298
    France

    Site Not Available

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