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Dietary Supplement
Fish Oil + Metformin for Polycystic Ovary Syndrome (PCOS Trial)
Phase 1
Recruiting
Led By Donna F Vine, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female
Age at time of enrollment > 18 to <30 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and postintervention at 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see how adding fish oil to the diet of overweight-obese young women with PCOS compares to the standard treatment with metformin in terms of their blood fats and how the body
Who is the study for?
This trial is for overweight or obese young women aged 18-30 with PCOS, who may also have type 2 diabetes. Participants should have high blood triglycerides and signs of insulin resistance. It's not suitable for those without these specific conditions.
What is being tested?
The study aims to compare the effects of fish oil supplements, metformin (a standard diabetes drug), and their combination on blood fats and certain lipoproteins in women with PCOS who are overweight or obese.
What are the potential side effects?
Potential side effects include digestive issues from fish oil like a fishy aftertaste, nausea, bloating, and diarrhea. Metformin can cause stomach upset, diarrhea, muscle pain, low blood sugar levels, and potentially vitamin B12 deficiency.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
Select...
I am between 18 and 30 years old.
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I have been diagnosed with PCOS, showing symptoms like irregular periods and high androgen levels.
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I am a young woman with a BMI over 25, considered overweight or obese.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and postintervention at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and postintervention at 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state
Secondary study objectives
Plasma hormones, testosterone, SHBG, Estrogen
Plasma insulin and glucose
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: MetforminExperimental Treatment1 Intervention
Metformin tablets (500 mg) 2/day 12 weeks
Group II: Fish Oil and MetforminExperimental Treatment1 Intervention
Combo of other 2 arms
Group III: Fish OilExperimental Treatment1 Intervention
Fish oil capsules 1200mg 6 tablets/day 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Fish Oil
2006
Completed Phase 4
~1320
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,229 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
146 Patients Enrolled for Polycystic Ovary Syndrome
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,527,286 Total Patients Enrolled
2 Trials studying Polycystic Ovary Syndrome
182 Patients Enrolled for Polycystic Ovary Syndrome
Alberta Diabetes InstituteOTHER
3 Previous Clinical Trials
61 Total Patients Enrolled
Heart and Stroke Foundation of CanadaOTHER
130 Previous Clinical Trials
72,611 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
146 Patients Enrolled for Polycystic Ovary Syndrome
Women and Children's Health Research Institute, CanadaOTHER
17 Previous Clinical Trials
24,720 Total Patients Enrolled
Donna F Vine, PhDPrincipal InvestigatorAssociate Professor