Nutrient Mixtures and Neurodevelopment

Completed

• Conditions: Neurodevelopment
• Interventions: Other: Nutrient mixtures

• Registration Number: NCT03420872
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Background: Adequate levels of beneficial nutrients are important for neurodevelopment. Although, nutrients are ingested in combination, considering nutrients as a mixture has not been studied with respect to health, such as neurodevelopment.

Objective: To examine the impact of prenatal and childhood nutrition mixtures on neurodevelopment.

Design: Participants included mother-child pairs in the Programming Research in Obesity, Growth Environment and Social Stress (PROGRESS) prospective birth cohort in Mexico City. Prenatal and child nutrition profiles were assessed among 65 and 329 children respectively by analyzing components of a food frequency questionnaire. Child neurodevelopmental outcomes at 4-6 years of age were measured using the McCarthy Scales of Children's Abilities (MSCA).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09-15
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Primary Completion: 2018-08-15
• Study Completion: 2018-08-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

Inclusion Criteria

Women of children:

• less than 20 weeks gestation at the start of the study
• at least 18 years of age
• and planned to reside in Mexico City for the next three years.

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Exclusion Criteria

Women of children:

• free of heart or kidney disease
• not use steroids or anti-epilepsy drugs
• not consume alcohol.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subset from PROGRESS cohort	Nutrient mixtures	Participants included children 4-6 years of age from mother-child pairs in the Programming Research in Obesity, Growth Environment and Social Stress (PROGRESS) prospective birth cohort in Mexico City

Primary Outcome Measures

Name	Time	Method
McCarthy Scales of Children's Abilities (MSCA)	at age 4	The MSCA consists of 18 short sub-tests that are weighted and combined to yield five scale scores or indexes - verbal, perceptual performance, quantitative, memory and motor - as well as an overall general cognitive index based on the first three scaled indexes. The McCarthy Scale index scores can range from 22 - 78 with higher index scores indicating better outcome.

Trial Locations

Locations (1)

National Institute of Public Health; 🇲🇽 Mexico City, Mexico