Breast CancerEVIDENSENCT01747720
Vitamin D and Mammographic Breast Density
A study testing Vitamin D3 in people with Breast Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
There is some evidence that vitamin D could be used to reduce breast cancer risk. Randomized controlled trials would provide definitive evidence about this effect. However, trials with breast cancer as outcome are expensive and time-consuming. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to 17 May 2017
- Phase
- Interventional
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- be premenopausal at baseline;
- have breast density of at least 20% at baseline;
- have normal baseline serum calcium (2,12-2,60 mmol/L) and serum creatinine (45-85 μmol/L);
- agree to have her mammogram at 12 months of follow-up at the same mammography clinic (same site) as the one where the mammogram at recruitment was done.
Who cannot join
- taking > 400 IU/day of supplemental vitamin D and refusing to reduce (≤ 400 IU/day) or cease such intake;
- taking > 600 mg/day of supplemental calcium and refusing to reduce (≤ 600 mg/day) or cease such intake;
- have contra-indications for use of vitamin D supplementation (hypersensitivity to vitamin D or its analogues; a history of renal calculi or hypercalcemia, hypervitaminosis D);
- taking medication suspected to interact with vitamin D: frequent use of antacids containing magnesium or aluminium; regular use of anticonvulsants (phenytoin, phenobarbital), digoxin, cholestyramine, colestipol, orlistat, mineral oil;
- have a personal history of breast cancer;
- have a personal history of cancer other than non-melanoma skin cancer within 5 last years;
- have had breast reduction or augmentation including breast implantation (or planning to undergo such surgery during the trial);
- be pregnant or planning a pregnancy in the next year.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du CHU de Québec, Hôpital du Saint-Sacrement
Québec, G1S 4L8
About this study
Official title: A Randomized Double-blind Placebo-controlled Trial of the Effect of Vitamin D Supplementation on Breast Density in Premenopausal Women
There is some evidence that vitamin D could be used to reduce breast cancer risk. Randomized controlled trials would provide definitive evidence about this effect. However, trials with breast cancer as outcome are expensive and time-consuming. Use of surrogate outcomes has been advocated to accelerate progress in the identification of interventions that could prevent breast cancer. Mammographic breast density is one of the strongest breast cancer risk indicators and is already used as a surrogate outcome in several breast cancer prevention trials. The aim of this double-blind randomized controlled trial is to determine whether daily oral supplementation with vitamin D3 (1,000, 2,000 or 3,000 IU) over a period of 1 year reduces breast density in premenopausal women compared to placebo. A total of 376 women (94 per arm) who live in Quebec City will be recruited. Showing that vitamin D reduces breast density would provide strong support for the idea that vitamin D can be a safe and inexpensive approach for the prevention of breast cancer.
Read the detailed description
OBJECTIVES
Primary:
- to determine whether adding oral supplementation with vitamin D3 (cholecalciferol) at doses of 1,000, 2,000 and 3,000 IU/d to baseline total vitamin D intake over a period of 12 months reduces mammographic breast density among premenopausal women at moderate to high risk of breast cancer who reside in the Quebec City area, Canada.
Secondary:
- to assess the net increase in 25(OH)D levels resulting from this vitamin D3 supplementation;
- to document the compliance with, and safety of, supplementation with tested doses of vitamin D3 over one year.
OUTLINE This study is a double-blind, placebo-controlled, randomized trial among premenopausal women who live in the Quebec City area and have ≥ 20% breast density at baseline.
The intervention consists of the addition, over baseline total vitamin D intake from food and supplements, of three different doses of vitamin D3 (1000, 2000 or 3000 IU/day) for a period of 12 months. There are four arms in the trial:
- Arm 1: 1,000 IU vitamin D3/d (1 tablet vitamin D 1000 IU + 2 tablets placebo);
- Arm 2: 2,000 IU vitamin D3/d (2 tablets vitamin D 1000 IU + 1 tablet placebo);
- Arm 3: 3,000 IU vitamin D3/d (3 tablets vitamin D 1000 IU);
- Arm 4: placebo (3 tablets placebo/d).
Vitamin D tablets (1000 IU tablets) and the placebo tablets are undistinguishable in size, shape, color and taste, and are manufactured by the same company.
- Conditions
- Breast Cancer
- Being tested
- Vitamin D3, Placebo
- Keywords
- breast cancer, mammographic breast density, vitamin D, prevention, randomized controlled trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
Given orally
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 (cholecalciferol) 1000 IU | Experimental | Oral vitamin D3 (cholecalciferol) supplementation, 1000 IU daily, for 12 months Receives: Dietary Supplement: Vitamin D3 |
| Vitamin D3 (cholecalciferol) 2000 IU | Experimental | Oral vitamin D3 (cholecalciferol) supplementation, 2000 IU daily, for 12 months Receives: Dietary Supplement: Vitamin D3 |
| Vitamin D3 (cholecalciferol) 3000 IU | Experimental | Oral vitamin D3 (cholecalciferol) supplementation, 3000 IU daily, for 12 months Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | daily, for 12 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammographic breast density
Difference in breast density between baseline and at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2017
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Jacques Brisson, M.D., Sc.D., Principal investigator, Centre de recherche du CHU de Québec, et Faculté de médecine de l'Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747720
- Sponsor's protocol ID
- DR-002-1373
- Acronym
- EVIDENSE
- Status last verified
- May 2017
- First submitted
- 10 Dec 2012
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: We will not share IPD. Results of the study are published in Cancer Epidemiology, Biomarkers and Prevention.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo-controlled Trial of the Effect of Vitamin D Supplementation on Breast Density in Premenopausal Women
- ClinicalTrials.gov ID
- NCT01747720
- Acronym / sponsor ID
- EVIDENSE / DR-002-1373
- Conditions
- Breast Cancer
- Keywords
- breast cancer, mammographic breast density, vitamin D, prevention, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Quebec Breast Cancer Foundation
- Study start
- Oct 2012
- Primary completion
- May 2017 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 12 Dec 2012 (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.
There is some evidence that vitamin D could be used to reduce breast cancer risk. Randomized controlled trials would provide definitive evidence about this effect. However, trials with breast cancer as outcome are expensive and time-consuming. Use of surrogate outcomes has been advocated to accelerate progress in the identification of interventions that could prevent breast cancer. Mammographic breast density is one of the strongest breast cancer risk indicators and is already used as a surrogate outcome in several breast cancer prevention trials. The aim of this double-blind randomized controlled trial is to determine whether daily oral supplementation with vitamin D3 (1,000, 2,000 or 3,000 IU) over a period of 1 year reduces breast density in premenopausal women compared to placebo. A total of 376 women (94 per arm) who live in Quebec City will be recruited. Showing that vitamin D reduces breast density would provide strong support for the idea that vitamin D can be a safe and inexpensive approach for the prevention of breast cancer.
Detailed description
OBJECTIVES
Primary:
- to determine whether adding oral supplementation with vitamin D3 (cholecalciferol) at doses of 1,000, 2,000 and 3,000 IU/d to baseline total vitamin D intake over a period of 12 months reduces mammographic breast density among premenopausal women at moderate to high risk of breast cancer who reside in the Quebec City area, Canada.
Secondary:
- to assess the net increase in 25(OH)D levels resulting from this vitamin D3 supplementation;
- to document the compliance with, and safety of, supplementation with tested doses of vitamin D3 over one year.
OUTLINE This study is a double-blind, placebo-controlled, randomized trial among premenopausal women who live in the Quebec City area and have ≥ 20% breast density at baseline.
The intervention consists of the addition, over baseline total vitamin D intake from food and supplements, of three different doses of vitamin D3 (1000, 2000 or 3000 IU/day) for a period of 12 months. There are four arms in the trial:
- Arm 1: 1,000 IU vitamin D3/d (1 tablet vitamin D 1000 IU + 2 tablets placebo);
- Arm 2: 2,000 IU vitamin D3/d (2 tablets vitamin D 1000 IU + 1 tablet placebo);
- Arm 3: 3,000 IU vitamin D3/d (3 tablets vitamin D 1000 IU);
- Arm 4: placebo (3 tablets placebo/d).
Vitamin D tablets (1000 IU tablets) and the placebo tablets are undistinguishable in size, shape, color and taste, and are manufactured by the same company.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 (cholecalciferol) 1000 IU | Experimental | Dietary Supplement: Vitamin D3Oral vitamin D3 (cholecalciferol) supplementation, 1000 IU daily, for 12 months |
| Vitamin D3 (cholecalciferol) 2000 IU | Experimental | Dietary Supplement: Vitamin D3Oral vitamin D3 (cholecalciferol) supplementation, 2000 IU daily, for 12 months |
| Vitamin D3 (cholecalciferol) 3000 IU | Experimental | Dietary Supplement: Vitamin D3Oral vitamin D3 (cholecalciferol) supplementation, 3000 IU daily, for 12 months |
| Placebo | Placebo comparator | Dietary Supplement: Placebodaily, for 12 months |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- be premenopausal at baseline;
- have breast density of at least 20% at baseline;
- have normal baseline serum calcium (2,12-2,60 mmol/L) and serum creatinine (45-85 μmol/L);
- agree to have her mammogram at 12 months of follow-up at the same mammography clinic (same site) as the one where the mammogram at recruitment was done.
Key exclusion criteria (8 listed)
- taking > 400 IU/day of supplemental vitamin D and refusing to reduce (≤ 400 IU/day) or cease such intake;
- taking > 600 mg/day of supplemental calcium and refusing to reduce (≤ 600 mg/day) or cease such intake;
- have contra-indications for use of vitamin D supplementation (hypersensitivity to vitamin D or its analogues; a history of renal calculi or hypercalcemia, hypervitaminosis D);
- taking medication suspected to interact with vitamin D: frequent use of antacids containing magnesium or aluminium; regular use of anticonvulsants (phenytoin, phenobarbital), digoxin, cholestyramine, colestipol, orlistat, mineral oil;
- have a personal history of breast cancer;
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 |
|---|---|---|
| Vitamin D3Also: CholecalciferolGiven orally | Dietary supplement | Vitamin D3 (cholecalciferol) 1000 IU, Vitamin D3 (cholecalciferol) 2000 IU, Vitamin D3 (cholecalciferol) 3000 IU |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Mammographic breast density
Time frame: 12 months
Difference in breast density between baseline and at 12 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 24 May 2017.
- Individual participant dataSharing planned: No. We will not share IPD. Results of the study are published in Cancer Epidemiology, Biomarkers and Prevention.
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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.
Jacques Brisson, M.D., Sc.D. principal investigator
Centre de recherche du CHU de Québec, et Faculté de médecine de l'Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Breast Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 4 inclusion and 8 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 24 May 2017. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Mammographic breast density (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2017.