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

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: calcium and cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01480869

VITACAL

VA 2010/12 (Other Identifier)

2010-023459-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

215 participants in 2 patient groups

Conventional vitamin D and calcium supplementation

Active Comparator group

Description:

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

Treatment:

Drug: calcium and cholecalciferol

Drug: calcium and cholecalciferol

vitamin D supplementation tailored to vitamin D deficiency

Experimental group

Description:

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

Treatment:

Drug: calcium and cholecalciferol

Drug: calcium and cholecalciferol