Prenatal choline supplementation to support fetal brain development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial evaluates maternal choline supplementation during pregnancy in abstinent participants to see if it can support infant recognition memory, postnatal growth, eyeblink conditioning, and information processing speed. The protocol mirrors a prior pilot and uses choline bitartrate versus placebo, enrolling about 50 pregnant women and their infants. Primary outcomes include infant recognition memory and postnatal growth measures, with secondary outcomes spanning eyeblink conditioning, postnatal length, and processing speed. Eligible participants are adults 18+ with singleton pregnancies between ≤20 weeks gestation, who have abstained from alcohol since conception and have low dietary choline intake. Exclusion criteria include illicit drug use, HIV, certain medical conditions, or plans to relocate before study completion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• University of Cape Town
  Cape Town, South Africa Recruiting

Study contacts

• Principal investigator: R. Colin Carter, MD, MMSc — Columbia University
• Study coordinator: R. Colin Carter, MD, MMSc
• Email: rcc2142@cumc.columbia.edu
• Phone: +12123052995

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Exploring how brain development affects social emotions and communication in young children

  This study looks at how the development of a child's brain affects their ability to express emotions and communicate as they grow from infants to young children.

  Recruiting Children's Hospital of Fudan University · Xiamen, Fujian · NCT05040542

• See if the Parenting Young Children Check-up helps with behavior in kids ages 2-5

  This trial tests the Parenting Young Children Check-up to see if it improves behavior and reduces parenting stress for families with young children in a Detroit pediatric clinic serving low-income families.

  Recruiting Early Phase 1 Wayne State University · Detroit, Michigan · NCT07750054

• Parenting Young Children Check-up in a Detroit clinic

  This trial tests whether the Parenting Young Children Check-up helps improve behavior, parenting, and stress for parents of 2- to 5-year-olds compared with usual care.

  Recruiting Early Phase 1 Wayne State University · Detroit, Michigan · NCT07734545

• Using virtual reality to trigger exercise-like responses in sedentary adults

  This study will test whether repeated short VR sessions that mimic exercise can produce exercise-like protein changes and improved endurance in sedentary adults with prediabetes.

  Recruiting Wayne State University · Detroit, Michigan · NCT07296991

• Timing of opioid administration and breathing changes after surgery

  This study watches adults who had general anesthesia and receive opioids after surgery to see if opioid timing and dose affect breathing changes measured by minute ventilation.

  Recruiting Wayne State University · Detroit, Michigan · NCT07227389

• Behavioral Activation delivered by peer recovery specialists in a community clinic

  This project will test whether Behavioral Activation delivered by peer recovery specialists helps adults with depression (and co-occurring substance use disorders) who receive care at a community behavioral health center.

  Recruiting Wayne State University · Detroit, Michigan · NCT07219394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.