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| ID | Type | Description | Link |
|---|---|---|---|
| VA 2010/12 | Other Identifier | VA 2010/12 | |
| 2010-023459-27 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium and cholecalciferol | Drug | Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRLC Val d'Aurelle-Paul Lamarque | Montpellier | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27029707 | Result | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| calcium and cholecalciferol | Drug | Tablet: calcium 500 mg bid + 2 ml drinkable solution cholecalciferol 100 000 IU whose schedule of administration depends on vitamin deficiency level:
|
|
| 6 months after crossover |
| Clinical and biological tolerance profile | According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0 | During treament administration (can last up to 24 months) |
| Treatment compliance | Treatment compliance will be assessed using a patient record book | During treatment administration (can last up to 24 months) |
| Quality of life | Quality of life is assessed using the EORTC QLQ-C30 questionnaire | 24 months |
| Impact of study treatments on bone and joint pains induced by aromatase inhibitors | During treatment administration (can last up to 24 months) |
| Changes in vitamin and calcium biological markers | Up to 24 months |
| Predictive value of individual biomarkers | Up to 24 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |