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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-22

Study Completion Date

2025-12-30

Brief Summary

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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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Detailed Description

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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

Conditions

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PCOS (Polycystic Ovary Syndrome)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Omega-3

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

Group Type EXPERIMENTAL

Omega 3 fatty acids

Intervention Type DRUG

1gm tab twice daily.

Omega -3 fatty acids

Intervention Type DRUG

1gm tablet twice daily.

placebo

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

Group Type PLACEBO_COMPARATOR

Omega 3 fatty acids

Intervention Type DRUG

1gm tab twice daily.

Omega -3 fatty acids

Intervention Type DRUG

1gm tablet twice daily.

Interventions

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Omega 3 fatty acids

1gm tab twice daily.

Intervention Type DRUG

Omega -3 fatty acids

1gm tablet twice daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No