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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
Awards & highlights
TOTS Trial Summary
This trial plans to learn more about how an omega-3 fatty acid supplement effects triglyceride levels in pregnancy. Triglycerides are a type of fat found in your blood. Your body converts extra calories into triglycerides to be stored and used later for energy. It is normal for triglyceride levels to go up during pregnancy however some women have levels that are ~30-40% higher than normal when they reach their third trimester of pregnancy. Having high triglycerides in pregnancy may be related to an increased chance of having a baby that is large for their age. The goal of this study is to determine if taking an omega-3 fatty acid
TOTS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maternal Fasting and Postprandial Triglycerides
TOTS 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
1,749 Previous Clinical Trials
2,164,020 Total Patients Enrolled
University of OklahomaOTHER
455 Previous Clinical Trials
95,616 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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