Using omega-3 supplements to lower triglycerides during pregnancy
Pilot RCT Intervention Targeting Elevated Triglycerides With a Point-of-Care Meter and Omega-3 Fatty Acids to Normalize Triglycerides and Fetal Growth
NA · University of Colorado, Denver · NCT04349475
This study tests if taking omega-3 supplements can help pregnant women lower their triglyceride levels to avoid complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 0 Years to 39 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT04349475 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of omega-3 fatty acid supplementation on triglyceride levels in pregnant women. It aims to determine whether these supplements can help manage elevated triglyceride levels, which can be common during pregnancy and may lead to complications such as having a larger-than-average baby. Participants will be given either omega-3 supplements or a control substance (safflower oil) to assess the impact on triglyceride levels. The study focuses on women with specific pre-pregnancy BMI and triglyceride levels.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 21-39 with a pre-pregnancy BMI of 28-39 and fasting triglyceride levels of 120 mg/dL or higher by 15 weeks of pregnancy.
Not a fit: Patients with pre-gestational diabetes, a history of gestational diabetes, or other specified health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help manage triglyceride levels in pregnant women, potentially reducing risks associated with high triglycerides.
How similar studies have performed: While there is ongoing research into omega-3 fatty acids, this specific approach to managing triglyceride levels in pregnancy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women between the ages of 21-39 yrs * Pre-pregnancy BMI 28-39 * Fasting Triglyceride ≥120 mg/dL measured by 15 wks Exclusion Criteria: * Pre-gestational diabetes or prediabetes * History of gestational diabetes, * History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension \<34wks * Tobacco or illicit substance use * Chronic steroid use
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado/Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Teri L Hernandez, PhD — University of Colorado, Denver
- Study coordinator: Teri L Hernandez, PhD
- Email: Teri.Hernandez@cuanschutz.edu
- Phone: 303-724-8538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy, triglycerides, glucose, adiposity, Air displacement plethysmography, Continuous glucose monitoring