Choline Supplementation for Child Development

Recruiting at 1 trial location

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Colorado, Denver

Disqualifiers: Fetal death, Chronic infections, Trimethylaminuria, Homocystinuria, others

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

Compensation: Varies

Number of Visits: 20

Duration: Approximately 24 weeks

600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What evidence supports the effectiveness of choline supplementation as a treatment for child development?

Research suggests that choline, a nutrient important for brain development, may have mild positive effects on cognitive outcomes in children, especially when used early in development. Some studies indicate that choline can help with neurodevelopmental delays and improve cognitive function in certain developmental disorders. ^{1 2 3 4 5}

Is choline supplementation safe for children?

Choline is an essential nutrient important for growth and development, and while deficiencies can lead to health issues, the safety of supplementation in children has been studied. In one study, children with intestinal failure were given choline supplements, and no adverse effects were reported, suggesting it is generally safe. However, more research is needed to fully understand its safety profile in different populations. ^{3 6 7 8 9}

How is choline supplementation unique as a treatment for child development?

Choline supplementation is unique because it is a non-drug treatment that provides an essential nutrient important for brain development, particularly during pregnancy and early childhood, potentially improving cognitive outcomes in children. ^{2 9 10 11 12}

What is the purpose of this trial?

The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcome is the child's behavior at four years of age as reported by the primary caregiver. Secondary outcomes include motor development, socio-emotional development, language development, and cognitive development. Potential contributors beyond the supplement, including maternal stress and placental function will also be assessed.

Research Team

Camille Hoffman, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for healthy pregnant women aged 18-45 with a normal BMI, who speak English or Spanish. It's not suitable for those with a history of fetal death, chronic infections like HIV, certain genetic disorders, or noncompliance issues.

Inclusion Criteria

I am a healthy pregnant woman aged between 18 and 45.

Prepregnancy BMI >18 and <45

Exclusion Criteria

My primary language is neither English nor Spanish.

I or my immediate family have a history of Homocystinuria.

Prior history of fetal death

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 1250 mg of choline or placebo daily from approximately 16 weeks gestation until delivery

Approximately 24 weeks

Visits at enrollment, and approximately at weeks 20, 28, 32

Follow-up

Children are monitored and assessed for developmental outcomes until 4 years of age

4 years

Treatment Details

Interventions

• Choline
• Placebo

Trial Overview The study tests if phosphatidylcholine (a nutritional supplement) given from the 16th week of pregnancy until birth can improve children's brain development and behavior by age four compared to a placebo.

Participant Groups

Group I: Drug: Choline Active Control 1 Intervention

Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery

Group II: Participants will take placebo Placebo Group 1 Intervention

Participants will take placebo. Corn oil every day in place of choline

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?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

Choline requirements are significantly higher for preterm infants (50-60 mg/kg/day) compared to term infants (17-18 mg/kg/day), highlighting the importance of adequate choline intake during rapid organ growth in the third trimester.

Most infant formulas do not provide sufficient choline or the appropriate types of choline components found in breast milk, indicating a need for reformulation and clearer labeling to ensure infants receive adequate choline for healthy development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choline Content of Term and Preterm Infant Formulae Compared to Expressed Breast Milk-How Do We Justify the Discrepancies? Shunova, A., Böckmann, KA., Minarski, M., et al.[2021]

Choline supplementation during pregnancy has been shown to improve cognitive outcomes in children, highlighting its importance as a non-pharmacological intervention for enhancing child development.

This systematic review analyzed 9 studies on various forms of choline supplementation (like choline chloride and phosphatidylcholine) and confirmed its effectiveness in promoting better cognitive abilities in offspring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Importance of choline during pregnancy and lactation: A systematic review]. Heras-Sola, J., Gallo-Vallejo, JL.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Neuropsychiatric development: two case reports about the use of dietary fish oils and/or choline supplementation in children. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Choline and docosahexaenoic acid during the first 1000 days and children's health and development in low- and middle-income countries. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Differential metabolism of choline supplements in adult volunteers. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The association between plasma choline, growth and neurodevelopment among Malawian children aged 6-15 months enroled in an egg intervention trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

One-carbon metabolism in neurodevelopmental disorders: using broad-based nutraceutics to treat cognitive deficits in complex spectrum disorders. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Choline Content of Term and Preterm Infant Formulae Compared to Expressed Breast Milk-How Do We Justify the Discrepancies? [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Oral choline supplementation in children with intestinal failure. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

Different choline supplement metabolism in adults using deuterium labelling. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Choline status and neurodevelopmental outcomes at 5 years of age in the Seychelles Child Development Nutrition Study. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Choline supplements: An update. [2023]

11. Spain pubmed.ncbi.nlm.nih.gov

[Importance of choline during pregnancy and lactation: A systematic review]. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

Serum choline in extremely preterm infants declines with increasing parenteral nutrition. [2021]