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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

Awards & highlights

VITAL Trial 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

VITAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mammographic breast density

Secondary outcome measures

Breast tissue

VITAL Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: 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 II: 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 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,609 Previous Clinical Trials

11,466,433 Total Patients Enrolled

2 Trials studying Benign Breast Disease

20,475 Patients Enrolled for Benign Breast Disease

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,929,773 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: Fish oil and vitamin D placebo, Vitamin D and fish oil, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for enrolment in this experiment at the present time?

"As per the info available on clinicaltrials.gov, this particular medical trial is no longer actively recruiting patients; it was first posted in July 2012 and last modified in April 2022. However, there are still 20 other studies that require participants at present."

Answered by AI

Are there specific qualifications that must be met to take part in this research?

"The requirements for this trial are that interested participants must have cystic breast disease and be between 55-67 years of age. A total of 3894 individuals can take part in the study."

Answered by AI