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Omega-3 Fatty Acid Supplement
Omega 3 Supplementation for Pregnancy (TOTS Trial)
N/A
Recruiting
Led By Teri L Hernandez, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 34 weeks gestational age
Summary
This trial aims to see if taking an omega-3 fatty acid supplement can help pregnant women with high triglyceride levels. High triglycerides can lead to having larger babies. The supplement might help control these fat levels in the blood. Omega-3 fatty acids, particularly DHA and EPA, have been studied for their potential benefits during pregnancy, including reducing preterm birth and improving fetal growth.
Who is the study for?
This trial is for pregnant women aged 21-39 with a pre-pregnancy BMI of 28-39 and fasting triglyceride levels ≥120 mg/dL measured by week 15. It excludes those on chronic steroids, using tobacco or illicit substances, or with histories of certain pregnancy complications like pre-eclampsia or diabetes.
What is being tested?
The study is testing if omega-3 fatty acid supplements can control the rise in blood fat (triglycerides) during the third trimester of pregnancy compared to safflower oil. High triglycerides are linked to having larger babies.
What are the potential side effects?
Potential side effects may include fishy aftertaste, upset stomach, or allergic reactions from omega-3 supplements; however, these are generally considered safe during pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 34 weeks gestational age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~34 weeks gestational age
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maternal Fasting and Postprandial Triglycerides
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Omega 3 SupplementationExperimental Treatment1 Intervention
Supplementation of 4g of DHA/EPA daily
Group II: Safflower Oil SupplementPlacebo Group1 Intervention
Supplementation of Safflower Oil daily
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,837 Total Patients Enrolled
University of OklahomaOTHER
473 Previous Clinical Trials
93,641 Total Patients Enrolled
Teri L Hernandez, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been taking steroids for a long time.You use tobacco or illegal drugs.You had high blood pressure or gave birth prematurely before 34 weeks during pregnancy due to pre-eclampsia or gestational hypertension.You have had diabetes during pregnancy in the past.You have diabetes or a condition called prediabetes before getting pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Safflower Oil Supplement
- Group 2: Omega 3 Supplementation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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