Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Vers... | NCT04694027

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

NCT04694027

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 5, 2021Actual

Enrollment

120Estimated

Phase

Phase 4

Conditions

Mastalgia

Interventions

Omega 3 fatty acid
VitaE

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2021Estimated

Primary Completion Date

Mar 2021Estimated

Completion Date

Mar 2021Estimated

First Submitted Date

Dec 31, 2020

First Submission Date that Met QC Criteria

Dec 31, 2020

First Posted Date

Jan 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2020

Last Update Posted Date

Jan 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group a	Active Comparator	will receive omega 3 plus vitamin E	Drug: Omega 3 fatty acid Drug: VitaE
Group b	Active Comparator	will receive vitamin E	Drug: VitaE
Group c	No Intervention	no intervention just reassurance and analgesics on need

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega 3 fatty acid	Drug	omega 3 1000 mg	group a
VitaE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
improvement of pain severity	improvement of pain on visual analogue scale	3 months

Secondary Outcomes

Measure	Description	Time Frame
improvement of radiological finding		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rehab Sabry	Contact	0201063314476		rehab.yassen@kasralainy.edu.eg
Heba El nahas	Contact	020104810684		hebagalal@kasralainy.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rehab Sabry		Cairo	Muslim	11231	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059373	Mastodynia

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015525	Fatty Acids, Omega-3
D024505	Tocopherols

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided