Choline Supplementation for Child Development

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking a choline supplement during pregnancy can enhance early brain development in children. The study will compare the effects of the supplement against a placebo to determine any differences in children’s behavior and other developmental milestones by age four. Pregnant women who are physically healthy and do not have chronic infections or a history of certain genetic conditions might be suitable candidates for this trial. Participants will take either the choline supplement or a placebo from about the 16th week of pregnancy until delivery. The goal is to assess whether the supplement can support better cognitive, motor, and socio-emotional growth in young children. As a Phase 1 trial, this research focuses on understanding how the choline supplement works in people, offering participants the opportunity to be among the first to receive this treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that taking choline supplements during pregnancy is generally safe. Choline plays a crucial role in the baby's brain development. Pregnant women who have taken choline supplements have not reported major negative effects.

Most children and adults tolerate choline well. Studies suggest that doses up to 1 gram per day are safe for children. This information indicates it is likely safe for pregnant women, even though the doses in this trial are higher.

Although detailed information about side effects during pregnancy is limited, the absence of serious problems in past studies is reassuring. Always consult a healthcare provider before starting any supplement. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about choline supplementation for child development because it introduces a promising approach to supporting brain growth. Unlike standard prenatal vitamins, which may not include choline, this treatment specifically targets brain development by providing an essential nutrient directly linked to cognitive function. Choline is crucial for the formation of cell membranes and the production of neurotransmitters, making it a vital component for developing a healthy nervous system. By directly supplementing phosphatidylcholine, this treatment could offer a more targeted and efficient way to enhance fetal brain development compared to conventional prenatal care.

What evidence suggests that choline supplementation might be an effective treatment for child development?

Research has shown that taking choline supplements during pregnancy may support the baby's brain development. Some studies suggest that choline could improve memory and intelligence by affecting the hippocampus, a brain region involved in these functions. However, other research has found mixed results, with some studies showing little or no benefit for children's brain development. Despite this, adequate choline intake during pregnancy remains important for the baby's overall brain health. This trial will compare the effects of choline supplementation with a placebo to further investigate its impact on brain development. While the data appears promising, more research is needed to fully understand how choline affects brain development. ^{1 2 3 6 7}

Who Is on the Research Team?

Camille Hoffman, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3723412/

Choline status and neurodevelopmental outcomes at 5 years ...

We postulated that choline exposure in early life could affect hippocampal development, thereby affecting memory and intelligence in children. Therefore, we ...

2.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK605544/

Choline Supplementation for Infants, Children, and Pregnant ...

For choline supplementation in children with FASD, most evidence showed little-to-no benefits for neurocognitive and neurodevelopmental outcomes, and brain ...

3.

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.

4.

cda-amc.ca

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

Choline Supplementation for Infants, Children, and ...

showed little-to-no benefits for neurocognitive and neurodevelopmental outcomes, and brain structure; limited evidence showed higher fishy body odour and some ...

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.

webmd.com

webmd.com/vitamins/ai/ingredientmono-436/choline

Choline - Uses, Side Effects, And More

Children: Choline is likely safe for most children when taken by mouth in appropriate amounts. Doses up to 1 gram daily for children 1-8 years of age, 2 grams ...

7.

ods.od.nih.gov

ods.od.nih.gov/factsheets/Choline-HealthProfessional/

Choline - Health Professional Fact Sheet

Choline overview for health professionals. Research health effects, dosing, sources, deficiency symptoms, side effects, and interactions ...