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Vitamin D and Mammographic Breast Density

NCT01747720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2017-05-24

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Given orally

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • Quebec Breast Cancer Foundation

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Jacques Brisson, M.D., Sc.D. · Centre de recherche du CHU de Québec, et Faculté de médecine de l'Université Laval

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-05-31
Completion
2017-05-17

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01747720 on ClinicalTrials.gov