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Dietary Fish Oil Intervention in Polycystic Ovary Syndrome (PCOS)

NCT04116203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-02-28

No results posted yet for this study

Summary

The primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.

Conditions

  • Polycystic Ovary Syndrome
  • Lipid Metabolism Disorders

Interventions

DRUG

Metformin

Manufacturer's standard 500 mg. Submission Control No.:128147

COMBINATION_PRODUCT

Fish Oil and Metformin

Combo of 2 other arms

DIETARY_SUPPLEMENT

Fish Oil

NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral

Sponsors & Collaborators

  • Women and Children's Health Research Institute, Canada

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Alberta Diabetes Institute

    collaborator OTHER

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Donna F Vine, PhD · Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-11-12
Completion
2020-11-12

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04116203 on ClinicalTrials.gov