Vitamin D and Mammographic Breast Density (EVIDENSE)

This study is currently recruiting participants.
Verified December 2012 by Centre Hospitalier Universitaire de Québec, CHU de Québec
Sponsor:
Collaborator:
Fondation du cancer du sein du Québec
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01747720
First received: December 10, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Dietary Supplement: Vitamin D3
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Double-blind Placebo-controlled Trial of the Effect of Vitamin D Supplementation on Breast Density in Premenopausal Women

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Mammographic breast density [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Difference in breast density between baseline and at 12 months


Estimated Enrollment: 376
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3 (cholecalciferol) 1000 IU
Oral vitamin D3 (cholecalciferol) supplementation, 1000 IU daily, for 12 months
Dietary Supplement: Vitamin D3
Given orally
Other Name: Cholecalciferol
Experimental: Vitamin D3 (cholecalciferol) 2000 IU
Oral vitamin D3 (cholecalciferol) supplementation, 2000 IU daily, for 12 months
Dietary Supplement: Vitamin D3
Given orally
Other Name: Cholecalciferol
Experimental: Vitamin D3 (cholecalciferol) 3000 IU
Oral vitamin D3 (cholecalciferol) supplementation, 3000 IU daily, for 12 months
Dietary Supplement: Vitamin D3
Given orally
Other Name: Cholecalciferol
Placebo Comparator: Placebo
daily, for 12 months
Dietary Supplement: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747720

Contacts
Contact: Sylvie Bérubé, Ph.D. 418-682-7511 ext 2175 sylvie.berube@uresp.ulaval.ca

Locations
Canada, Quebec
Centre de recherche du CHU de Québec, Hôpital du Saint-Sacrement Recruiting
Québec, Quebec, Canada, G1S 4L8
Contact: Sylvie Bérubé       sylvie.berube@uresp.ulaval.ca   
Principal Investigator: Jacques Brisson, M.D., Sc.D.         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Fondation du cancer du sein du Québec
Investigators
Principal Investigator: Jacques Brisson, M.D., Sc.D. Centre de recherche du CHU de Québec, et Faculté de médecine de l'Université Laval
  More Information

Additional Information:
No publications provided

Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01747720     History of Changes
Other Study ID Numbers: DR-002-1373
Study First Received: December 10, 2012
Last Updated: December 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
breast cancer
mammographic breast density
vitamin D
prevention
randomized controlled trial

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014