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Vitamin D and fish oil for Benign Breast Disease (VITAL Trial)

N/A
Waitlist Available
Led By Rulla M Tamimi, ScD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years

Summary

This trial is investigating whether taking daily dietary supplements of vitamin D3 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke. This ancillary study will examine whether vitamin D effects mammographic breast density, mammographic texture features, and gene expression profiles in breast biopsy tissue.

Eligible Conditions
  • Benign Breast Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mammographic breast density
Secondary study objectives
Breast tissue

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Vitamin D and fish oilActive Control1 Intervention
Vitamin D3 (cholecalciferol), 2000 IU per day and 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])
Group II: Fish oil and vitamin D placeboActive Control1 Intervention
Vitamin D placebo and 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])
Group III: Vitamin D and fish oil placeboActive Control1 Intervention
Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo
Group IV: Vitamin D placebo and fish oil placeboPlacebo Group1 Intervention
vitamin D placebo + fish oil placebo

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,664 Previous Clinical Trials
11,831,092 Total Patients Enrolled
2 Trials studying Benign Breast Disease
20,475 Patients Enrolled for Benign Breast Disease
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,008,134 Total Patients Enrolled
1 Trials studying Benign Breast Disease
106 Patients Enrolled for Benign Breast Disease
Rulla M Tamimi, ScDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Vitamin D and fish oil Clinical Trial Eligibility Overview. Trial Name: NCT02239874 — N/A
Benign Breast Disease Research Study Groups: Vitamin D and fish oil, Fish oil and vitamin D placebo, Vitamin D and fish oil placebo, Vitamin D placebo and fish oil placebo
Benign Breast Disease Clinical Trial 2023: Vitamin D and fish oil Highlights & Side Effects. Trial Name: NCT02239874 — N/A
Vitamin D and fish oil 2023 Treatment Timeline for Medical Study. Trial Name: NCT02239874 — N/A
~292 spots leftby Nov 2025
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