Increased Choline Intake for Child Cognitive Development During Pregnancy

Overseen By Richard L Canfield, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Cornell University

Must not be taking: Liver, kidney affecting drugs

Disqualifiers: Metabolic, gastrointestinal, high omega-3, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 6 months

40 Participants Needed

Trial Summary

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.

Research Team

Barbara J Strupp, PhD

Principal Investigator

Cornell University

Eligibility Criteria

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

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)

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Experimental Dose Experimental Treatment 1 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 Dose Placebo Group 1 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.

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

Approved in United States as Choline for:

• Dietary supplement

Approved in European Union as Choline for:

• Dietary supplement

Approved in Canada as Choline for:

• Dietary supplement

Who Is Running the Clinical Trial?

Cornell University

Lead Sponsor

Trials

179

Recruited

14,090,000+