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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 weeks
Treatment ~ Varies
Follow Up ~34 weeks gestational age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 34 weeks gestational age for reporting.

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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,543 Total Patients Enrolled
University of OklahomaOTHER
455 Previous Clinical Trials
97,570 Total Patients Enrolled
Teri L Hernandez, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

Media Library

Intervention Omega 3 Supplementation (Omega-3 Fatty Acid Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04349475 — N/A
Pregnancy Research Study Groups: Safflower Oil Supplement, Omega 3 Supplementation
Pregnancy Clinical Trial 2023: Intervention Omega 3 Supplementation Highlights & Side Effects. Trial Name: NCT04349475 — N/A
Intervention Omega 3 Supplementation (Omega-3 Fatty Acid Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04349475 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must individuals possess to partake in this clinical experiment?

"To qualify for this trial, individuals must be in a reproductive state and within the age range of 0-39. At present, approximately 40 participants need to be enrolled."

Answered by AI

Does the study encompass participants aged 75 and above?

"The criteria for taking part in this trial demands that participants are between the ages of 0 and 39. Additionally, there are 21 clinical trials specifically tailored to those younger than 18 and 34 studies available for elderly patients above 65 years old."

Answered by AI

How many enrollees are part of this research effort?

"Indeed, the details on clinicaltrials.gov demonstrate that this clinical trial is actively searching for volunteers. It was initially posted on November 29th 2021 and last updated April 12th 2022, with 40 participants being sought from two sites."

Answered by AI

Are potential participants still able to join in this research endeavor?

"Affirmative. According to information available on clinicaltrials.gov, this study is currently inviting volunteers and was first made public on November 29th 2021. As of April 12th 2022, the trial has two locations where it needs 40 participants in total."

Answered by AI

Who else is applying?

What state do they live in?
California
Oklahoma
Colorado
How old are they?
18 - 65
What site did they apply to?
University of Colorado/Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Email
~12 spots leftby Apr 2025