Effect of Omega-3 Supplementation as Add on Therapy on Metabolic Syndrome in Women With Polycystic Ovary Syndrome.

NCT07036952 | Enrolling By Invitation DMC

• 1 other identifier: BSMMU/2025/3950
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Omega-3 works to treat Polycystic ovary syndrome in women. It will also learn about the safety of drug Omega-3. The main questions it aims to answer are: Does Omega-3 lower the number of times participant to treat metabolic syndrome What medical problems do participants have when taking drug Omega-3.Researchers will compare drug Omega-3 to a placebo (a look-alike substance that contains no drug) to see if drug Omega-3 used to treat PCOS. Participants will: Take Omega-3 or a placebo every day for 3 months Visit the clinic once every 6 weeks for checkups and tests Keep a diary of their symptoms and menstrual history.

Conditions

PCOS (Polycystic Ovary Syndrome)

Outcome Measures

Primary Outcomes (1)

• Effect of Omega-3 Supplementation as Add on Therapy on Metabolic Syndrome in Women with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

  Changes in Lipid profile (Triglycerides, HDL-Cholesterol) Omega3 reduce Triglyceride and increase HDL Cholesterol Changes in CRP Plasma Omega-3 level (changes in plasma DHA and EPA conc. from baseline to 12 weeks) Changes in BMI,Omega3 reduce weight as well as BMI. Improvement of menstrual cycle regularity. Improvement of hirsutism.

  12 weeks.

Study Arms (2)

Omega-3

EXPERIMENTAL

Participants received Omega-3 1gm tablet orally twice daily for 12 weeks.

Drug: Omega 3 fatty acids; Drug: Omega -3 fatty acids

placebo

PLACEBO COMPARATOR

Participants received Omega-3 1gm placebo matching Omega-3 tablet orally twice daily for 12 weeks

Drug: Omega 3 fatty acids; Drug: Omega -3 fatty acids

Interventions

Omega -3 fatty acids DRUG

1gm tablet twice daily.

Omega-3; placebo

Eligibility Criteria

• Age: 18 Years - 36 Years
• Gender Eligibility Details: Female age range:18-36 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age above 18 years up to 35 years
• Newly diagnosed case of PCOS.

You may not qualify if:

• History of diabetes mellitus (except those meeting metabolic syndrome criteria)
• Any chronic illness (e.g. liver disease, kidney disease, cardiovascular disease)
• Any acute or chronic infective or inflammatory disease.
• Patients receiving Omega-3 supplementation within the last three months.
• Known allergy to fish oil or Omega-3 supplements.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Fariba kabir

Dhaka, Bsmmu, 1000, Bangladesh

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator: Dr. Fariba Kabir, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka Bangladesh.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: April 22, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)