Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient

NCT ID: NCT04694027

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mastalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group a

will receive omega 3 plus vitamin E

Group Type ACTIVE_COMPARATOR

Omega 3 fatty acid

Intervention Type DRUG

omega 3 1000 mg

VitaE

Intervention Type DRUG

vitamin e 400 mg

Group b

will receive vitamin E

Group Type ACTIVE_COMPARATOR

VitaE

Intervention Type DRUG

vitamin e 400 mg

Group c

no intervention just reassurance and analgesics on need

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Omega 3 fatty acid

omega 3 1000 mg

Intervention Type DRUG

VitaE

vitamin e 400 mg

Intervention Type DRUG

Eligibility Criteria

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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.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rehab Sabry

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rehab Sabry

Cairo, Muslim, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Rehab Sabry

Role: CONTACT

0201063314476

Heba El nahas

Role: CONTACT

020104810684

Facility Contacts

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Rehab Sabry

Role: primary

Other Identifiers

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Omega 3 & vit E for mastalgia

Identifier Type: -

Identifier Source: org_study_id

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