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Enrolling by Invitation

NCT Number: NCT07036952

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

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.

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fariba kabir

Dhaka, Bsmmu, 1000, Bangladesh

About this study

This research will be a single center study, utilizing a double-blind, randomized placebo-controlled trial design. A total of 62 women, with newly diagnosed PCOS, age range from 18-36 years will randomly be assigned to receive either Omega-3 supplementation (1gm twice daily) or a placebo for 12 weeks. Biochemical and anthropometric measurements, including lipid profile, fasting blood sugar, blood pressure, inflammatory markers (CRP) and body composition such as BMI, waist circumference will be assessed at baseline and post-intervention. Follow-up assessments will be conducted three months after supplementation to evaluate the sustainability of metabolic changes. For independent samples; t-test will be utilized to analyze the average differences in metabolic biomarker levels between the group receiving Omega-3 supplements and the group receiving a placebo. The Chi-square test or Fisher's exact test will be employed to compare the percentage of participants may show a significant change in metabolic biomarker in the group that received Omega-3 versus the group that received a placebo. Pearson or Spearman correlation tests will be used to explore any relationships between baseline Omega-3 levels and baseline inflammatory marker (CRP) and lipid profile levels, as well as between the change in Omega-3 levels and the change in inflammatory marker (CRP) and lipid profile levels

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• Rotterdam criteria for PCOS (Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS) 2004).

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

Exclusion criteria

• Pregnancy and lactating mother.

  • 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.
  • Exclusion of PCOS mimicking disease include hyperprolactinemia, adrenal hyperandrogenism, ovarian hyperandrogenism, cushing's syndrome, acromegaly etc.
  • Known allergy to fish oil or Omega-3 supplements.

Treatment and study plan

Omega 3 fatty acids

Drug

1gm tab twice daily.

Omega -3 fatty acids

Drug

1gm tablet twice daily.

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

    Time frame: 12 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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