Recruiting

Choline & DHA

Sponsor:

Cornell University

Code:

NCT03194659

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 21 - 40

Healthy Volunteers: Accepted

Interventions

Choline

Study Details

Brief summary:

The purpose of this study is to determine whether choline supplementation influences the availability of docosahexaenoic acid throughout pregnancy.

Conditions

Pregnancy

Study ID

NCT03194659

Start date

Oct 5, 2017

Status verified date

Jan, 2020

Completion date

Dec 5, 2021

Anticipated

Primary completion date

Dec 5, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • healthy, singleton pregnant women gestational weeks 12-16, ages 21-40, willingness to comply with the study protocol

Exclusion Criteria:

  • Habitually high choline/DHA intake
  • Pre-pregnancy BMI >32
  • Pregnancy complications and comorbidities (at baseline and throughout the study)
  • Current smokers, drinkers, or drug users

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Placebo

Administration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the placebo arm of the trial, no additional choline chloride will be added to the cocktail.

experimental: Supplemental Choline

Administration of the deuterated choline chloride will take place in a grape juice cocktail solution. For individuals in the experimental arm of the trial, supplemental choline chloride will be added to the cocktail.

Interventions

Choline

Choline chloride is a water soluble choline salt that will be provided in a juice solution to participants to be consumed daily. The intervention will increase dietary choline intake by 500mg/day.

Primary outcome measure

  • DHA-Containing Phosphatidylcholine Species in Circulating Erythrocytes [ Time Frame: Gestational Weeks 12-16 through Gestational Weeks 38-41 ]

Central Contacts and Locations

Central contacts

Marie A. Caudill, PhD, RD

607-254-7456mac379@cornell.edu

Kevin C. Klatt, PhD, RD

267-978-8889klatt@bcm.edu

Locations

Human Metabolic Research Unit, Cornell University

Recruiting

Ithaca, New York, United States, 14853

Contacts

Erica Bender, MSN, CNM

607-255-9417eb572@cornell.edu

Principal Investigator:

Marie A. Caudill, PhD, RD

More Information

Sponsor

Cornell University

Last update posted

Jan 18, 2020

Last verified

Jan, 2020

Keywords

  • Nutrition
  • choline
  • pregnancy
  • docosahexaenoic acid
  • DHA
  • fatty acids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cornell University on 2020-01-18.