Nutrient Mixtures and Neurodevelopment

October 10, 2019 updated by: Icahn School of Medicine at Mount Sinai

Prenatal and Childhood Nutrient Mixtures Predict Neurodevelopmental Outcomes Among Children in Mexico City

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

329

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • National Institute of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy pregnant women living in Mexico city from 2006-2009 seeking health care in clinics (Parent-child pairs) and their children at 4 - 6 years of age.

Description

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.

Exclusion Criteria:

Women of children:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subset from PROGRESS cohort
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
Other: Nutrient mixtures
consumption of a mixture of beneficial nutrients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
McCarthy Scales of Children's Abilities (MSCA)
Time Frame: 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.
at age 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Robert Wright, MD, MPH, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Mara Tellez-Rojo, PhD, National Institute of Public Health, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2006

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 15, 2018

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 14, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GCO 12-1417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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