NCT05859126

Brief Summary

The goal of this 13-year follow up of a randomized control trial is to study the effect of maternal choline supplementation on offspring cognition in adolescence. The main question\[s\] it aims to answer are: Does a higher dose of maternal choline choline (930 mg/d day supplementation) lead to improved cognition in adolescence including hippocampal-dependent episodic memory and executive functioning when compared to lower dose supplementation (480 mg/d). In this follow-up of a clinical trial participants will complete online cognition testing and emotion testing.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 23, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

March 30, 2023

Last Update Submit

August 21, 2024

Conditions

Cognitive Deficit in AttentionExecutive DysfunctionEmotional Regulation

Keywords

adolescenceemotioncognitioncholine

Outcome Measures

Primary Outcomes (4)

  • CANTAB Signal Detection test

    To measure selective and sustained attention where sensitivity to stimulus ranges from 0 (bad) to 1 (good)

    at 13 years of age

  • CANTAB Delayed Matching to Sample

    To measure memory where scoring is based on percent correct where 0% is bad and 100% is excellent), Paired Associates Learning (where scoring is based on total errors, where 0 is best), and Pattern Recognition Memory (where outcome is measured as percentage of correct trials and latency (speed of participant's response).)

    at 13 years of age

  • CANTAB Spatial Working Memory

    To measure executive function (where outcome measure is number of errors and lower is better),

    at 13 years of age

  • CANTAB Cambridge Gambling

    To measure executive function (where outcome measure is number of errors and lower is better),

    at 13 years of age

Secondary Outcomes (2)

  • Child Behavior Checklist (CBCL)

    at 13 years of age

  • Youth Self Report (CBCL

    at 13 years of age

Study Arms (2)

Maternal Choline Supplementation 930 mg/d

EXPERIMENTAL

Supplementation of 930 mg/d from early second trimester through birth. Offspring are followed for cognitive outcomes.

Dietary Supplement: Maternal Choline Supplementation 930 mg/d

Maternal Choline Supplementation 480mg/d

ACTIVE COMPARATOR

Supplementation of 480 mg/d from early second trimester through birth.Offspring are followed for cognitive outcomes.

Dietary Supplement: Maternal Choline Supplementation 480 mg/d

Interventions

Maternal Choline Supplementation 930 mg/dDIETARY_SUPPLEMENT

Mothers were supplemented with choline (930mg/d) from second trimester through birth. This is a 13 year follow up of their offspring.

Maternal Choline Supplementation 930 mg/d
Maternal Choline Supplementation 480 mg/dDIETARY_SUPPLEMENT

Mothers were supplemented with choline (480 mg/d) from second trimester through birth. This is a 13 year follow up of their offspring.

Maternal Choline Supplementation 480mg/d

Eligibility Criteria

Age13 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Offspring of mothers from the original choline feeding trial
  • Testing will commence when the child reaches 13 years of age (determined by date of birth of participant)

You may not qualify if:

  • Failure to follow the study protocol regarding test procedures and questionnaires
  • Lack of internet access with the requisite speed and stability needed to support the online testing tools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell University, Division of Nutritional Sciences

Ithaca, New York, 14850, United States

Location

Related Publications (1)

  • Roth SA, Lam AE, Strupp BJ, Canfield RL, Larson EA. The Effect of Maternal Choline Intake on Offspring Cognition in Adolescence: Protocol for a 14-year Follow-Up of a Randomized Controlled Feeding Trial. JMIR Res Protoc. 2025 Jul 11;14:e73508. doi: 10.2196/73508.

    PMID: 40644695DERIVED

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Barbara Strupp, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

May 15, 2023

Study Start

June 23, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)