Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal

• ClinicalTrials.gov Identifier: NCT03028857
• Recruitment Status: Active, not recruiting
• First Posted: January 23, 2017
• Last Update Posted: January 26, 2022
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Child Development; Prenatal Stress	Drug: Choline; Dietary Supplement: Placebo	Phase 1

Detailed Description:

Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.

Participants in this double-blind study will be randomly assigned to receive either placebo or 1250 mg of choline daily throughout pregnancy, until delivery. Vital signs will be taken, potential side effects will be assessed, and study medication will be given at each visit. Blood samples will be taken at enrollment and approximately at weeks 20, 28, 32. Children will be followed and assessed until 4 years of age.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-blind Trial of Phosphatidylcholine Supplementation During Pregnancy: Impact on Attention and Social Withdrawal at 4 Years of Age
• Actual Study Start Date: June 12, 2017
• Estimated Primary Completion Date: December 2026
• Estimated Study Completion Date: December 2026

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Participants will take placebo; Participants will take placebo. Corn oil every day in place of choline	Dietary Supplement: Placebo; Mothers are instructed to take the capsules twice a day, five placebo corn oil capsules at breakfast and five placebo corn oil capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.; Other Name: Corn oil every day in place of choline
Active Comparator: Drug: Choline; Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery	Drug: Choline; Mothers are instructed to take the capsules twice a day, five 450 mg phosphatidylcholine capsules at breakfast and five phosphatidylcholine 450 mg capsules at dinner. Increased awareness into the benefits of choline by obstetricians and pregnant women, as well as our recently published results from an observational study showing a wide distribution of serum choline concentrations in pregnant women, suggest that serum choline concentration is a more apt independent variable for analyses.; Other Name: Phosphatidylcholine

Outcome Measures

Primary Outcome Measures :

1. Behavior rated on the Child Behavior Checklist. [ Time Frame: 4 Years of age ]
   Our primary behavioral outcome is behavior as measured by the Child Behavior Checklist at 4 years of age.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• General Health: Other than pregnancy related illnesses, physically healthy expectant mothers
• ages 18-45 years
• prepregnancy BMI>18 and <45

Exclusion Criteria:

• Prior history of fetal death
• Current personal history of chronic infections, including HIV

• Current personal or family history out to first degree relatives of

  1. Trimethylaminuria
  2. Homocystinuria
• Primary language other than English or Spanish
• Evidence of noncompliance

Contacts and Locations

Locations

United States, Colorado

UCHealth

Aurora, Colorado, United States, 80045

Saint Joseph Hospital

Denver, Colorado, United States, 80218

Sponsors and Collaborators

University of Colorado, Denver

Investigators

• Principal Investigator: Camille Hoffman, MD; University of Colorado, Denver

More Information

Publications:

Ross RG, Hunter SK, Hoffman MC, McCarthy L, Chambers BM, Law AJ, Leonard S, Zerbe GO, Freedman R. Perinatal Phosphatidylcholine Supplementation and Early Childhood Behavior Problems: Evidence for CHRNA7 Moderation. Am J Psychiatry. 2016 May 1;173(5):509-16. doi: 10.1176/appi.ajp.2015.15091188. Epub 2015 Dec 7. Erratum in: Am J Psychiatry. 2016 Jul 1;173(7):735.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03028857
• Other Study ID Numbers: 16-1510
• First Posted: January 23, 2017
• Last Update Posted: January 26, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: A copy of the locked database with all outcome, safety, and demographic measures will be provided as a supplement to the primary publication.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Choline; Lipotropic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Lipid Regulating Agents; Nootropic Agents