Effects of Vitamin D in Patients With Breast Cancer

NCT01948128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2016-02-03

No results posted yet for this study

Summary

This protocol is a randomized, phase 2 "window of opportunity" trial assessing the biological effects of short term oral vitamin D administration on breast cancer clinical and translational markers in patients awaiting surgery at the Ottawa Hospital. It takes advantage of the current wait times (2-8 weeks) for breast cancer surgery as a "window of opportunity" to rapidly assess biological changes with vitamin D intake.

Conditions

Interventions

DRUG

Vitamin D3

Participants will take 4 capsules of Vitamin D which equals 40,000 IU by mouth daily during the wait time between diagnosis and surgery.

OTHER

Placebo

Participants will take 4 capsules of placebo by mouth daily during the wait time between diagnosis and surgery.

Sponsors & Collaborators

  • Canadian Breast Cancer Foundation

    collaborator OTHER
  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Angel Arnaout, Dr. · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Canada

Study Locations

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Entities

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 NCT01948128 on ClinicalTrials.gov