Clinical trial · Interventional
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.
NCT01480869CI-TRIAL-00105349VITACALcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium and cholecalciferol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional vitamin D and calcium supplementation
- description
- Conventional vitamin D and calcium supplementation with 2 daily OROCAL VITAMINE D3® (500 mg calcium/200 IU cholecalciferol) tablets.
- interventionNames
- Drug: calcium and cholecalciferol
- type
- EXPERIMENTAL
- label
- vitamin D supplementation tailored to vitamin D deficiency
- 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
- interventionNames
- Drug: calcium and cholecalciferol
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTJacot 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