40 Participants Needed

Increased Choline Intake for Child Cognitive Development During Pregnancy

BJ
RL
Overseen ByRichard L Canfield, PhD
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during pregnancy.

Who Is on the Research Team?

BJ

Barbara J Strupp, PhD

Principal Investigator

Cornell University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Healthy
Singleton pregnancy (carrying one baby)
Intending to deliver at Cayuga Medical Center
See 5 more

Exclusion Criteria

I take more than 50 mg/day of choline supplements.
I have a history of health issues related to metabolism or digestion.
Development of pregnancy-related complications during the study (i.e. gestational diabetes, gestational hypertension, preeclampsia, genetic abnormalities, or miscarriage)
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 550 mg choline supplement or a 25 mg placebo daily during the second and third trimesters of pregnancy

Approximately 6 months

Follow-up

Participants' infants are monitored for cognitive and affective outcomes at ages 5, 7, 10, and 13 months

13 months

What Are the Treatments Tested in This Trial?

Interventions

  • Choline
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental DoseExperimental Treatment1 Intervention
Group II: Control DosePlacebo Group1 Intervention

Choline is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Choline for:
🇪🇺
Approved in European Union as Choline for:
🇨🇦
Approved in Canada as Choline for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cornell University

Lead Sponsor

Trials
179
Recruited
14,090,000+
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