Vitamin D and Mammographic Breast Density

NCT01747720 | Completed DMC

• 1 other identifier: DR-002-1373
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mammographic breast density

  Difference in breast density between baseline and at 12 months

  12 months

Study Arms (4)

Vitamin D3 (cholecalciferol) 1000 IU

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Vitamin D3 (cholecalciferol) 2000 IU

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Vitamin D3 (cholecalciferol) 3000 IU

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

daily, for 12 months

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Given orally

Also known as: Cholecalciferol

Vitamin D3 (cholecalciferol) 1000 IU; Vitamin D3 (cholecalciferol) 2000 IU; Vitamin D3 (cholecalciferol) 3000 IU

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Quebec Breast Cancer Foundation: collaborator

Study Sites (1)

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

Québec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Jacques Brisson, M.D., Sc.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: May 17, 2017
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)