PCOS (Polycystic Ovary Syndrome)NCT07036952
Effect of Omega-3 Supplementation as Add on Therapy on Metabolic Syndrome in Women With Polycystic Ovary Syndrome.
A study testing Omega 3 fatty acids and Omega -3 fatty acids in people with PCOS (Polycystic Ovary Syndrome), run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Omega 3 fatty acids and Omega -3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteBangladesh
- Study dates
- 22 Apr 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the detailed description
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
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Omega 3 fatty acids, Omega -3 fatty acids
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acidsDrug
1gm tab twice daily.
Omega -3 fatty acidsDrug
1gm tablet twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | Participants received Omega-3 1gm tablet orally twice daily for 12 weeks. Receives: 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 Receives: Drug: Omega 3 fatty acids; Drug: Omega -3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start22 Apr 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fariba kabir, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036952
- Sponsor's protocol ID
- BSMMU/2025/3950
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07036952
- Acronym / sponsor ID
- BSMMU/2025/3950
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Drug: Omega 3 fatty acids, Drug: Omega -3 fatty acidsParticipants received Omega-3 1gm tablet orally twice daily for 12 weeks. |
| placebo | Placebo comparator | Drug: Omega 3 fatty acids, Drug: Omega -3 fatty acidsParticipants received Omega-3 1gm placebo matching Omega-3 tablet orally twice daily for 12 weeks |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 fatty acids1gm tab twice daily. | Drug | Omega-3, placebo |
| Omega -3 fatty acids1gm tablet twice daily. | Drug | Omega-3, placebo |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 fatty acids and Omega -3 fatty acids in people with PCOS (Polycystic Ovary Syndrome), run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.