Clinical trial · Interventional
Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer
A PHASE II Multicentric Trial Evaluating a High Dose Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer Treated by Adjuvant Chemotherapy
NCT04091178CI-TRIAL-00040623OPTIVITcompletedPhase 2ClinicalTrials.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)
An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy. A calcium supplementation will be prescribed in parallel. An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy
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 |
|---|---|---|---|
| VITAMIN D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VITAMIN D SUPPLEMENTATION ARM
- description
- On day 1 of every chemotherapy cycle, the patient will be receive an oral solution of vitamin D (UVEDOSE/calciferol). In parallel,a calcium supplementation is prescribed.
- interventionNames
- Dietary Supplement: VITAMIN D
Primary outcomes (1)
- measure
- Normalisation of Vitamin D level
- timeFrame
- from the Cycle 1 to cycle 6 (each cycle is 21 days)
- description
- percentage of vitamin D level normalisation
Secondary outcomes (4)
- measure
- initial vitamin D and calcium level
- timeFrame
- at cycle 1( one cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast adenocarcinoma should receive 6 cycles of adjuvant chemotherapy * Women ≥ 18 years old (no age limit) * Performance status :0 or 1 * Patients must be affiliated to a Social Security System * Signed informed consent obtained before any study specific procedures. * Vitamin D deficiency confirmed ( vitamin D result must be \< at 30 ng/ml) Exclusion Criteria: * Metastatic disease * Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years * calcium or colecalciferol contraindications (vitamin D hypersensitivity - disease or an other condition result in hypercalcaemia or hypercalciuria -Calcic lithiasis- high vitamin D level) * Presence of the following diseases in the last 3 years : endocrinal disease, A phosphor calcic disorder treated by vitamin D supplementation at 1000 UI/day or more (this patient who have received a dose \< 1000 UI/day, will be included after have to stop Vitamin D at least 48 hours ) - Osteopenia or osteoporosis confirmed treated * Concomittant treatment with an other experimental product * Pregnant or breastfeeding women * Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
References
Publications (13)
- RESULTCavalier E, Delanaye P, Chapelle JP, Souberbielle JC. Vitamin D: current status and perspectives. Clin Chem Lab Med. 2009;47(2):120-7. doi: 10.1515/CCLM.2009.036. PMID 19099529
- RESULTSinotte M, Diorio C, Berube S, Pollak M, Brisson J. Genetic polymorphisms of the vitamin D binding protein and plasma concentrations of 25-hydroxyvitamin D in premenopausal women. Am J Clin Nutr. 2009 Feb;89(2):634-40. doi: 10.3945/ajcn.2008.26445. Epub 2008 Dec 30. PMID 19116321
- RESULTHolick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available. PMID 17634462
- RESULTBischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA. 2005 May 11;293(18):2257-64. doi: 10.1001/jama.293.18.2257. PMID 15886381
- RESULTTang BM, Eslick GD, Nowson C, Smith C, Bensoussan A. Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis. Lancet. 2007 Aug 25;370(9588):657-66. doi: 10.1016/S0140-6736(07)61342-7. PMID 17720017
- RESULTRoux C, Bischoff-Ferrari HA, Papapoulos SE, de Papp AE, West JA, Bouillon R. New insights into the role of vitamin D and calcium in osteoporosis management: an expert roundtable discussion. Curr Med Res Opin. 2008 May;24(5):1363-70. doi: 10.1185/030079908x301857. Epub 2008 Apr 2. PMID 18387220
- RESULTBischoff-Ferrari HA, Dawson-Hughes B, Willett WC, Staehelin HB, Bazemore MG, Zee RY, Wong JB. Effect of Vitamin D on falls: a meta-analysis. JAMA. 2004 Apr 28;291(16):1999-2006. doi: 10.1001/jama.291.16.1999. PMID 15113819