- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04694027
Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient (FCC)
December 31, 2020 updated by: Rehab Sabry, Cairo University
to identify the effect of omega-3 plus vitamin E cosupplementation on mastalgia in patients with FCC and to compare its effect with that of vitamin E only.
Study Overview
Detailed Description
120 patients will be enrolled in the study and divided into three groups each group consisted 40 patient then the severity of mastalgia in the three groups before, through and after intervention.
Radiological assessment was done before and after the intervention.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rehab Sabry
- Phone Number: 0201063314476
- Email: rehab.yassen@kasralainy.edu.eg
Study Contact Backup
- Name: Heba El nahas
- Phone Number: 020104810684
- Email: hebagalal@kasralainy.edu.eg
Study Locations
-
-
Muslim
-
Cairo, Muslim, Egypt, 11231
- Rehab Sabry
-
Contact:
- Rehab Sabry
- Email: rehab.yassen@kasralainy.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- all females with mastalgia aged 18 to 55
Exclusion Criteria:
Pregnant and lactating women, patient who had a recent breast abscess or breast drainage, patient used omega-3 and vitamin E supplementation before the trial and postmenopausal women.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group a
will receive omega 3 plus vitamin E
|
omega 3 1000 mg
vitamin e 400 mg
|
Active Comparator: Group b
will receive vitamin E
|
vitamin e 400 mg
|
No Intervention: Group c
no intervention just reassurance and analgesics on need
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improvement of pain severity
Time Frame: 3 months
|
improvement of pain on visual analogue scale
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
improvement of radiological finding
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2021
Primary Completion (Anticipated)
March 1, 2021
Study Completion (Anticipated)
March 1, 2021
Study Registration Dates
First Submitted
December 31, 2020
First Submitted That Met QC Criteria
December 31, 2020
First Posted (Actual)
January 5, 2021
Study Record Updates
Last Update Posted (Actual)
January 5, 2021
Last Update Submitted That Met QC Criteria
December 31, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Omega 3 & vit E for mastalgia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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