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OpenTrials
Completed

NCT Number: NCT03420872

Nutrient Mixtures and Neurodevelopment

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).

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Key information

Conditions

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Public Health

Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrient mixtures

Other

consumption of a mixture of beneficial nutrients

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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