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Vitamin D and Mammographic Breast Density (EVIDENSE)

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Vitamin D3

Placebo

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, mammographic breast density, vitamin D, prevention, randomized controlled trial

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Centre de recherche du CHU de Québec, Hôpital du Saint-Sacrement

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3 (cholecalciferol) 1000 IU

Vitamin D3 (cholecalciferol) 2000 IU

Vitamin D3 (cholecalciferol) 3000 IU

Placebo

Arm Description

Oral vitamin D3 (cholecalciferol) supplementation, 1000 IU daily, for 12 months

Oral vitamin D3 (cholecalciferol) supplementation, 2000 IU daily, for 12 months

Oral vitamin D3 (cholecalciferol) supplementation, 3000 IU daily, for 12 months

daily, for 12 months

Outcomes

Primary Outcome Measures

Mammographic breast density

Difference in breast density between baseline and at 12 months

Secondary Outcome Measures

Full Information

NCT ID

NCT01747720

First Posted

December 10, 2012

Last Updated

May 23, 2017

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Quebec Breast Cancer Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01747720

Brief Title

Vitamin D and Mammographic Breast Density

Acronym

EVIDENSE

Official Title

A Randomized Double-blind Placebo-controlled Trial of the Effect of Vitamin D Supplementation on Breast Density in Premenopausal Women

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CHU de Quebec-Universite Laval

Collaborators

Quebec Breast Cancer Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast cancer, mammographic breast density, vitamin D, prevention, randomized controlled trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

405 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D3 (cholecalciferol) 1000 IU

Arm Type

Experimental

Arm Description

Oral vitamin D3 (cholecalciferol) supplementation, 1000 IU daily, for 12 months

Arm Title

Vitamin D3 (cholecalciferol) 2000 IU

Arm Type

Experimental

Arm Description

Oral vitamin D3 (cholecalciferol) supplementation, 2000 IU daily, for 12 months

Arm Title

Vitamin D3 (cholecalciferol) 3000 IU

Arm Type

Experimental

Arm Description

Oral vitamin D3 (cholecalciferol) supplementation, 3000 IU daily, for 12 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

daily, for 12 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Cholecalciferol

Intervention Description

Given orally

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Mammographic breast density

Description

Difference in breast density between baseline and at 12 months

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques Brisson, M.D., Sc.D.

Organizational Affiliation

Centre de recherche du CHU de Québec, et Faculté de médecine de l'Université Laval

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de recherche du CHU de Québec, Hôpital du Saint-Sacrement

City

Québec

ZIP/Postal Code

G1S 4L8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We will not share IPD. Results of the study are published in Cancer Epidemiology, Biomarkers and Prevention.

Learn more about this trial

Vitamin D and Mammographic Breast Density

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