Pilot Study of Prenatal Choline Supplementation

NCT07699393 | Recruiting Phase 2 DMC

• 1 other identifier: UCTCHOLINERCTPHASEB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomized, placebo-controlled trial (RCT; NCT04395196) of prenatal choline supplementation is ongoing (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed. The study design was based on a pilot feasibility study in 70 heavy-drinking pregnant women. Infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning than those in the placebo arm. Infants born to both the choline- and placebo-treated mothers were small at birth, but those in the choline arm showed considerable catch-up growth in weight and head circumference by 6.5 months, which persisted through 12 months. At 12 months, infants in the choline arm showed markedly better recognition memory compared to placebo-treated on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ. Of note, infants with heavy prenatal alcohol exposure whose mothers were in the active choline treatment arm performed better on FTII novelty preference neurobehavioral testing than infants in an observational study that was running in parallel who had no prenatal alcohol exposure. These pilot findings indicate that any beneficial effects of prenatal choline supplementation seen may be due in part or entirely due to general beneficial effects on fetal brain development rather than mechanisms that are specific to the teratogenic effects of alcohol. Thus, the aim of this pilot study is to enroll and randomize 50 alcohol-abstaining pregnant women to participate in an identical study protocol (same study procedures and primary and secondary outcomes) to NCT04395196, which includes only alcohol-consuming pregnant women. Effect sizes between this pilot, non-drinking group and the larger study of alcohol-consuming women will be compared to explore the degree to which prenatal choline supplementation benefits growth and neurobehavior in infants without prenatal alcohol exposure and to explore the degree to which beneficial treatment effects of choline are specific to prenatal alcohol exposure.

Conditions

Brain Development; Choline Nutrition

Keywords

Choline; Prenatal nutrition; dietary supplementation

Outcome Measures

Primary Outcomes (3)

• Infant recognition memory

  Novelty preference from the Fagan Test of Infant Intelligence

  12 months

• Postnatal infant weight gain

  6.5 months

• Postnatal growth in infant head circumference

  6.5 months

Secondary Outcomes (2)

• Infant information processing speed

  12 months

• Postnatal growth in infant length

  6.5 months

Study Arms (2)

High-dose choline supplementation

EXPERIMENTAL

2 g choline cation per day

Dietary Supplement: Choline bitartrate

Placebo

PLACEBO COMPARATOR

Placebo identical to active treatment in appearance, taste, and smell.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Provided in beverage form

Placebo

Choline bitartrate DIETARY_SUPPLEMENT

Provided in beverage form.

High-dose choline supplementation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 yr
• ≤20 wk gestation
• Singleton pregnancy
• Abstinence from alcohol since conception (by report)
• Current choline dietary intake \<1 g/day
• Language fluency in English or Afrikaans

You may not qualify if:

• Use of methamphetamine or other illicit drugs other than marijuana during the past year
• HIV positive
• Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems)
• Having another child enrolled in the trial from a previous pregnancy
• Plans for mother or child to move away from the area prior to study completion

Sponsors & Collaborators

• Columbia University: collaborator
• Wayne State University: lead
• University of Cape Town: collaborator

Study Sites (1)

University of Cape Town

Cape Town, South Africa

RECRUITING

MeSH Terms

Interventions

Choline

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• R. Colin Carter, MD, MMSc

  Columbia University

  PRINCIPAL INVESTIGATOR

• Sandra W Jacobson, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Joseph L Jacobson, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Ernesta M Meinjtes, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

R. Colin Carter, MD, MMSc

CONTACT

+12123052995; rcc2142@cumc.columbia.edu

Sandra W Jacobson, PhD

CONTACT

+13139935454; sandra.jacobson@wayne.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 13, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: We will share data as described above after publication of the main findings.
• Access Criteria: Requests should be made to the principle investigators.

Locations

ZA (1)