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Dietary Supplement

Choline Supplementation for Pregnant Women and Offspring Cognitive Development (CholTeens Trial)

N/A

Waitlist Available

Led By Barbara Strupp, PhD

Research Sponsored by Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 13 years of age

Awards & highlights

CholTeens Trial Summary

This trial will measure if higher levels of maternal choline during pregnancy can improve adolescent cognition.

Who is the study for?

This trial is for teenagers who are 13 years old and were born to mothers who participated in the original choline feeding study. It's designed to see if their mom's intake of choline during pregnancy affects their thinking and emotional skills now.Check my eligibility

What is being tested?

Researchers are looking at two different doses of choline given to pregnant women: one group took 480 mg per day, while another took a higher dose of 930 mg per day. They want to know if kids whose moms had more choline do better on tests that measure memory and problem-solving.See study design

What are the potential side effects?

Since this study involves cognitive testing rather than medication or treatment interventions, there aren't direct side effects like you'd expect with drugs. The focus is on assessing cognitive functions through online tests.

CholTeens Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 13 years of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 13 years of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 13 years of 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

CANTAB Cambridge Gambling

CANTAB Delayed Matching to Sample

CANTAB Signal Detection test

+1 more

Secondary outcome measures

Child Behavior Checklist (CBCL)

Youth Self Report (CBCL

Side effects data

From 2014 Phase 4 trial • 60 Patients • NCT01749982

13%

Diarrhea

13%

Fever

Chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Choline Bitartrate

Betaine

Choline Bitartrate + Betaine

CholTeens Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Maternal Choline Supplementation 930 mg/dExperimental Treatment1 Intervention

Supplementation of 930 mg/d from early second trimester through birth. Offspring are followed for cognitive outcomes.

Group II: Maternal Choline Supplementation 480mg/dActive Control1 Intervention

Supplementation of 480 mg/d from early second trimester through birth.Offspring are followed for cognitive outcomes.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cornell UniversityLead Sponsor

166 Previous Clinical Trials

14,089,834 Total Patients Enrolled

Barbara Strupp, PhDPrincipal InvestigatorCornell University

Media Library

Maternal Choline Supplementation 480 mg/d (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05859126 — N/A

Attention Deficit Disorder Research Study Groups: Maternal Choline Supplementation 930 mg/d, Maternal Choline Supplementation 480mg/d

Attention Deficit Disorder Clinical Trial 2023: Maternal Choline Supplementation 480 mg/d Highlights & Side Effects. Trial Name: NCT05859126 — N/A

Maternal Choline Supplementation 480 mg/d (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05859126 — N/A

Frequently Asked Questions

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

Is the age range for this trial limited to those below 70 years old?

"This trial has set a lower limit of age 13 and an upper cap of 18 for potential participants."

Answered by AI

Who is eligible to become a participant in this experiment?

"To participate in this medical experiment, potential subjects must have a diagnosis of attention deficit disorder and be between the ages 13-18. Currently, 26 candidates are being accepted."

Answered by AI

Is this trial recruiting new participants at the present?

"Clinicaltrials.gov has reported that this particular medical trial is no longer recruiting participants, having been posted on July 1st 2023 and last edited May 12th 2023. Yet there are still 647 other trials actively looking for enrolment across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Maternal Choline Supplementation and Offspring Cognition in Adolescence

2023. "Maternal Choline Supplementation and Offspring Cognition in Adolescence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05859126.