Breast CancerPhase 3VITACALNCT01480869
Study of Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients
A Phase 3 study testing calcium and cholecalciferol in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- calcium and cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 13Show fewer
- Calcium lithiasis and tissue calcification
- Hypervitaminosis D
- Presence of significant comorbidities:
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Being tested
- calcium and cholecalciferol
- Keywords
- Breast cancer, Vitamin D supplementation, in neoadjuvant, adjuvant setting
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium and cholecalciferolDrug
Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid
calcium and cholecalciferolDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: calcium and cholecalciferol |
| 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:
* 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 Receives: Drug: calcium and cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (9)
Baseline vitamin D/calcium status in this patient population
Measured: Baseline
Normalization rate of serum 25-OHD level
Measured: 12, 18 and 24 months
Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy
Measured: 6 months after crossover
Clinical and biological tolerance profile
According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.0
Measured: During treament administration (can last up to 24 months)
Treatment compliance
Treatment compliance will be assessed using a patient record book
Measured: During treatment administration (can last up to 24 months)
Quality of life
Quality of life is assessed using the EORTC QLQ-C30 questionnaire
Measured: 24 months
Impact of study treatments on bone and joint pains induced by aromatase inhibitors
Measured: During treatment administration (can last up to 24 months)
Changes in vitamin and calcium biological markers
Measured: Up to 24 months
Predictive value of individual biomarkers
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480869
- Sponsor's protocol ID
- VITACAL
- Other IDs
- VA 2010/12, 2010-023459-27
- Acronym
- VITACAL
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2011
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27029707
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01480869
- Acronym / sponsor ID
- VITACAL / VITACAL
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Vitamin D supplementation, in neoadjuvant, adjuvant setting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional vitamin D and calcium supplementation | Active comparator | Drug: calcium and cholecalciferolConventional 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 | Drug: calcium and cholecalciferolConventional 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcium and cholecalciferolTablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid | Drug | Conventional vitamin D and calcium supplementation |
| calcium and cholecalciferolTablet: 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 | Drug | vitamin D supplementation tailored to vitamin D deficiency |
Primary outcome
To evaluate the increase in normalization of serum vitamin D level
Time frame: 6 months
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.
9 secondary outcomes
Baseline vitamin D/calcium status in this patient population
Time frame: Baseline
Normalization rate of serum 25-OHD level
Time frame: 12, 18 and 24 months
Normalization rate of serum 25-OHD level in control patients who shift to experimental strategy
Time frame: 6 months after crossover
Clinical and biological tolerance profile
Time frame: During treament administration (can last up to 24 months)
Treatment compliance
Time frame: During treatment administration (can last up to 24 months)
Quality of life
Time frame: 24 months
Impact of study treatments on bone and joint pains induced by aromatase inhibitors
Time frame: During treatment administration (can last up to 24 months)
Changes in vitamin and calcium biological markers
Time frame: Up to 24 months
Predictive value of individual biomarkers
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication: PubMed 27029707Jacot 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing calcium and cholecalciferol in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the increase in normalization of serum vitamin D level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.