NCT04694027

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

December 31, 2020

Last Update Submit

December 31, 2020

Conditions

Mastalgia

Outcome Measures

Primary Outcomes (1)

  • improvement of pain severity

    improvement of pain on visual analogue scale

    3 months

Secondary Outcomes (1)

  • improvement of radiological finding

    3 months

Study Arms (3)

group a

ACTIVE COMPARATOR

will receive omega 3 plus vitamin E

Drug: Omega 3 fatty acidDrug: VitaE

Group b

ACTIVE COMPARATOR

will receive vitamin E

Drug: VitaE

Group c

NO INTERVENTION

no intervention just reassurance and analgesics on need

Interventions

Omega 3 fatty acidDRUG

omega 3 1000 mg

group a
VitaEDRUG

vitamin e 400 mg

Group bgroup a

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • all females with mastalgia aged 18 to 55

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehab Sabry

Cairo, Muslim, 11231, Egypt

Location

MeSH Terms

Conditions

Mastodynia

Interventions

Fatty Acids, Omega-3Tocopherols

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsVitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Rehab Sabry

CONTACT

0201063314476rehab.yassen@kasralainy.edu.eg

Heba El nahas

CONTACT

020104810684hebagalal@kasralainy.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 5, 2021

Study Start

January 1, 2021

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)