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

NCT ID: NCT01480869

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional vitamin D and calcium supplementation

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

Group Type: ACTIVE_COMPARATOR

calcium and cholecalciferol

Intervention Type: DRUG

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

vitamin D supplementation tailored to vitamin D deficiency

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

Group Type: EXPERIMENTAL

calcium and cholecalciferol

Intervention Type: DRUG

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

Interventions

calcium and cholecalciferol

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRLC Val d'Aurelle-Paul Lamarque

Montpellier, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 27029707 (View on PubMed)

Other Identifiers

VA 2010/12

Identifier Type: OTHER

Identifier Source: secondary_id

2010-023459-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VITACAL

Identifier Type: -

Identifier Source: org_study_id