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

NCT01480869 | Completed Phase 3

• 3 other identifiers: VITACALVA 2010/122010-023459-27
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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 supplementation.

Conditions

Breast Cancer

Keywords

Breast cancer; Vitamin D supplementation; in neoadjuvant; adjuvant setting

Outcome Measures

Primary Outcomes (1)

• To evaluate the increase in normalization of serum vitamin D level

  To compare the increase in normalization of serum vitamin D level adjusted to baseline level in patients receiving either vitamin D supplementation tailored to vitamin D deficiency or conventional vitamin D supplementation.

  6 months

Secondary Outcomes (9)

• Baseline vitamin D/calcium status in this patient population

  Baseline

• Normalization rate of serum 25-OHD level

  12, 18 and 24 months

• Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy

  6 months after crossover

• Clinical and biological tolerance profile

  During treament administration (can last up to 24 months)

• Treatment compliance

  During treatment administration (can last up to 24 months)

Study Arms (2)

Conventional vitamin D and calcium supplementation

ACTIVE COMPARATOR

Conventional vitamin D and calcium supplementation with 2 daily OROCAL VITAMINE D3® (500 mg calcium/200 IU cholecalciferol) tablets.

Drug: calcium and cholecalciferol

vitamin D supplementation tailored to vitamin D deficiency

EXPERIMENTAL

Conventional calcium supplementation with 2 daily OROCAL 500® (500 mg calcium) tablets to suck + vitamin D3 supplementation (UVÉDOSE®, cholecalciferol, 100 000 IU drinkable solution, 2 ml vial) whose schedule of administration depends on vitamin deficiency level: * 100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25OHD level \< 10 ng/mL * 100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25OHD level \< 20 ng/mL * 100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25OHD level \< 30 ng/mL

Drug: calcium and cholecalciferol

Interventions

calcium and cholecalciferol DRUG

Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid

Conventional vitamin D and calcium supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- Proved vitamin D deficiency as defined by serum vitamin D level lower than 30 ng/ml (75 nmol/L).

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

CRLC Val d'Aurelle-Paul Lamarque

Montpellier, 34298, France

Location

Related Publications (1)

• 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.

  PMID: 27029707 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Calcium; Cholecalciferol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: November 29, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)