Maternal Choline Supplementation and Offspring Cognition in Adolescence

Part of paid clinical trials in Ithaca, New York.

Sponsor
Cornell University
Study ID
NCT05859126
Status
Enrolling By Invitation

Conditions

  • Cognitive Deficit in Attention
  • Emotional Regulation
  • Executive Dysfunction

Eligibility Criteria

Sex
ALL
Age
13 Years - 13 Years
Healthy Volunteers
Accepted

Interventions

  • Maternal Choline Supplementation 930 mg/d — DIETARY_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 480 mg/d — DIETARY_SUPPLEMENT
    Mothers were supplemented with choline (480 mg/d) from second trimester through birth. This is a 13 year follow up of their offspring.

Study Details

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.

Key Dates

Start date
Jun 23, 2023
Status verified
Aug 2024
Primary completion
Oct 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Maternal Choline Supplementation 930 mg/d
    Supplementation of 930 mg/d from early second trimester through birth. Offspring are followed for cognitive outcomes.
  • Active Comparator: Maternal Choline Supplementation 480mg/d
    Supplementation of 480 mg/d from early second trimester through birth.Offspring are followed for cognitive outcomes.

Primary Outcome Measure

CANTAB Signal Detection test [ Time Frame: at 13 years of age ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cornell University, Division of Nutritional SciencesIthacaNew York14850-

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By research site
Cornell University, Division of Nutritional Sciences· Ithaca, NY

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