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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how extra choline intake during pregnancy might affect a child's brain development and mood. Participants will consume a special grape juice containing either a high or low amount of choline daily until delivery. The study seeks healthy pregnant women carrying one baby who plan to deliver at Cayuga Medical Center. As an unphased trial, it offers a unique opportunity to contribute to understanding the potential benefits of choline for future generations.

Will I have to stop taking my current medications?

If you are currently using medications that affect liver or kidney function or child outcomes, you will need to stop taking them to participate in the study. The trial does not specify other medication restrictions, but you should discuss your current medications with the study team.

Is there any evidence suggesting that increased choline intake during pregnancy is safe?

Studies have shown that choline supplements are generally safe when taken in recommended amounts. During pregnancy, choline plays a crucial role in the baby's brain development. The Institute of Medicine recommends a daily intake of 450 mg of choline for pregnant women. In this trial, the dose is slightly higher at 550 mg per day.

Research also indicates that choline is well-tolerated, with rare side effects. Pregnant individuals, including those with special dietary needs, are often advised to increase their choline intake. Insufficient choline can lead to deficiencies, potentially affecting both the mother and the baby.

Overall, choline supplements are considered safe for pregnant women, especially when taken as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about increasing choline intake during pregnancy because choline is believed to play a crucial role in developing a child's brain. Unlike other prenatal supplements that focus on vitamins like folic acid or iron, choline specifically supports cognitive development, potentially boosting memory and learning capabilities in children. This approach is unique as choline is delivered through a simple, daily grape juice cocktail, making it an easy addition to a pregnant person's routine. By targeting brain development directly, this treatment could offer a new way to enhance cognitive outcomes from the earliest stages of life.

What evidence suggests that increased choline intake might be effective for child cognitive development during pregnancy?

This trial will compare an experimental dose of choline with a control dose to evaluate its effects on child cognitive development during pregnancy. Studies have suggested that increased choline intake during pregnancy may enhance children's brain function. Research shows that adequate choline supports healthy brain development in babies. Some studies link choline intake during pregnancy with improved thinking and learning abilities in children. While animal studies support these benefits, research in humans continues. Overall, early findings suggest potential benefits for children's brain development, but further research is needed to confirm these effects in people. ^{1 2 4 6 7}

Who Is on the Research Team?

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

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 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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10709661/

Choline Supplementation in Pregnancy: Current Evidence ... Studies have suggested that increased choline intake during pregnancy may positively influence cognitive outcomes in children, potentially ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323000868

Association between Maternal Choline, Fetal Brain ... We studied associations between prenatal and early postnatal choline intake, brain development, and neurocognitive function of children.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9303951/

Prenatal choline supplementation improves child sustained ... The few studies that have evaluated the enduring effects of maternal choline intake on offspring cognition in humans are inconclusive. 38 , 39 ...

4. mdpi.com mdpi.com/2072-6643/17/5/886

Choline During Pregnancy and Child Neurodevelopment Animal studies suggest that choline supplementation during pregnancy improves cognitive outcomes in the offspring. This review aims to determine whether higher ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00332124

Safety and Effectiveness of Taking Choline Supplements ... Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development.

6. infantrisk.com infantrisk.com/content/choline-during-pregnancy-lactation

Choline During Pregnancy and Lactation | InfantRisk ... According to the Institute of Medicine (now known as the National Academy of Medicine), pregnant women should consume 450 mg/day of choline from ...

7. cda-amc.ca cda-amc.ca/sites/default/files/pdf/htis/2024/RC1531%20Choline%20Supplementation.pdf

Choline Supplementation for Infants, Children, and ... recommend that all pregnant people, including those with gestational diabetes mellitus or on vegan or vegetarian diets, increase their choline intake through ...