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Dietary Supplement

Increased Choline Intake for Child Cognitive Development During Pregnancy

N/A

Recruiting

Led By Barbara J 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

21-40 years old

Between 12-18 weeks pregnant at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up infant ages of 5, 7, 10, and 13 months

Awards & highlights

Study Summary

This trial looks at how choline affects cognitive and emotional outcomes in the children of women who took it during pregnancy.

Who is the study for?

This trial is for healthy pregnant women carrying one baby, between 12-18 weeks along, with a pre-pregnancy BMI under 35. Participants must be aged 21-40, planning to stay in Ithaca, NY area and deliver at Cayuga Medical Center. Excluded are those with high omega-3 intake, substance use during pregnancy, non-approved supplement use, certain health conditions or medications affecting metabolism or child outcomes.Check my eligibility

What is being tested?

The study is testing the effects of two different levels of choline supplementation on child cognitive development: a higher dose (550 mg/day) versus a much lower dose (25 mg/day), given to pregnant women throughout their pregnancy.See study design

What are the potential side effects?

Choline is generally safe but can cause side effects like fishy body odor when taken in large amounts. Other possible side effects include sweating, digestive issues such as nausea or diarrhea, and vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 40 years old.

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I am between 3 to 4.5 months pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ infant ages of 5, 7, 10, and 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~infant ages of 5, 7, 10, and 13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and infant ages of 5, 7, 10, and 13 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Effects of Maternal Choline Supplementation on Emotion Regulation: Face-to-Face Still-Face Paradigm Scores

The Effects of Maternal Choline Supplementation on Emotion Regulation: Lab-TAB/Frustation Task Scores

The Effects of Maternal Choline Supplementation on Infant Sustained Focused Attention: Mean Sustained Focused Attention Score

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental DoseExperimental Treatment1 Intervention

Participants will consume a 15 mL grape juice cocktail solution that contains 550 mg of choline once daily for the duration of their pregnancy.

Group II: Control DosePlacebo Group1 Intervention

Participants will consume a 15 mL grape juice cocktail solution that contains 25 mg of choline once daily for the duration of their pregnancy.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Cornell UniversityLead Sponsor

166 Previous Clinical Trials

14,089,820 Total Patients Enrolled

Barbara J Strupp, PhDPrincipal InvestigatorCornell University

Media Library

Choline (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04987099 — N/A

Pregnancy Research Study Groups: Experimental Dose, Control Dose

Pregnancy Clinical Trial 2023: Choline Highlights & Side Effects. Trial Name: NCT04987099 — N/A

Choline (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987099 — N/A

Frequently Asked Questions

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

What is the current tally of participants in this experiment?

"That is correct. According to clinicaltrials.gov, this medical trial initially advertised on December 13th 2020 and was most recently updated on February 7th 2022. Recruitment of 40 subjects at a single site is required for the study's completion."

Answered by AI

Is the enrollment process of this research still open?

"According to clinicaltrials.gov, the recruitment phase for this medical investigation is ongoing. The trial was first posted on December 13th 2020 and underwent its most recent revision on February 7th 2022."

Answered by AI

Who is eligible to partake in this investigation?

"This medical trial is enrolling 40 expectant mothers between the ages of 21 and 40. In order to qualify, patients must have a BMI lower than 35 in the three months prior to pregnancy (estimated or known), be carrying a single baby, fall within 12-18 weeks pregnant at screening, reside near Ithaca NY for the duration of study treatment, agree to all procedures outlined by researchers, and plan on delivering their child at Cayuga Medical Center."

Answered by AI

Is the enrollment for this research project limited to individuals over 65 years old?

"To participate in this research, individuals must be between the ages of 21 and 40. Separate studies for those below 18 or above 65 years old are available with a total of 55 trials combined."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Increased Maternal Choline Intake on Child Cognitive Development

2020. "Effects of Increased Maternal Choline Intake on Child Cognitive Development". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04987099.