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Personalized vitamin d dosing may beat standard approach in breast cancer patients

NCT ID NCT01480869

Disease control Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving vitamin D based on a patient's deficiency level works better than a standard dose. 215 breast cancer patients on chemotherapy received either a fixed daily supplement or a tailored dose. The goal was to see which method normalizes vitamin D levels faster and more safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vitamin D and calcium supplements
What this could lead to
If successful, this could show that personalized vitamin D dosing is better at correcting deficiencies in breast cancer patients, potentially improving bone health and overall well-being during chemotherapy.
What could go wrong
This trial is completed and focuses on vitamin D levels, not cancer outcomes. It may not affect cancer recurrence or survival, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

215 people

The number who actually took part.

Start date

Jul 2011

Finished

Dec 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast adenocarcinoma breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • CRLC Val d'Aurelle-Paul Lamarque

    Montpellier, 34298, France

More trials for these conditions

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