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

Mastalgia Clinical Trial

— FCC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04694027
• Other study ID #: Omega 3 & vit E for mastalgia
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2021
• Est. completion date: March 2021

Study information

• Verified date: December 2020
• Source: Cairo University
• Contact: Rehab Sabry
• Phone: 0201063314476
• Email: rehab.yassen[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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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Related Conditions & MeSH terms

• Mastalgia

Intervention

Drug:
• Omega 3 fatty acid
omega 3 1000 mg
• VitaE
vitamin e 400 mg

Locations

Country	Name	City	State
Egypt	Rehab Sabry	Cairo	Muslim

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of pain severity	improvement of pain on visual analogue scale	3 months
Secondary	improvement of radiological finding		3 months