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CompletedNCT03420872Updated Oct 14, 2019

Nutrient Mixtures and Neurodevelopment

An observational study in Neurodevelopment, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in Mexico. Open to participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2019-10-14.

Sponsored by Icahn School of Medicine at Mount Sinai · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
329
Ages
18 Years to 44 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Neurodevelopment

Keywords

  • Nutrition
  • Nutrients
  • Mixtures
  • Neurodevelopment
  • Prenatal
  • Children
03

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

Women of children:

  • free of heart or kidney disease
  • not use steroids or anti-epilepsy drugs
  • not consume alcohol.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
329 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherNutrient mixtures

    consumption of a mixture of beneficial nutrients

05

What researchers measure

Primary outcomes

  1. McCarthy Scales of Children's Abilities (MSCA)

    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.

    Time frame: at age 4

06

Study locations

1 site
  • National Institute of Public Health
    Mexico City, Mexico
07

References and documents

Publications

  • Munoz-Rocha TV, Tamayo Y Ortiz M, Romero M, Pantic I, Schnaas L, Bellinger D, Claus-Henn B, Wright R, Wright RO, Tellez-Rojo MM. Prenatal co-exposure to manganese and depression and 24-months neurodevelopment. Neurotoxicology. 2018 Jan;64:134-141. doi: 10.1016/j.neuro.2017.07.007. Epub 2017 Jul 17. PubMed 28728787 ↗
  • Rodosthenous RS, Burris HH, Svensson K, Amarasiriwardena CJ, Cantoral A, Schnaas L, Mercado-Garcia A, Coull BA, Wright RO, Tellez-Rojo MM, Baccarelli AA. Prenatal lead exposure and fetal growth: Smaller infants have heightened susceptibility. Environ Int. 2017 Feb;99:228-233. doi: 10.1016/j.envint.2016.11.023. Epub 2016 Dec 5. PubMed 27923585 ↗
  • Rosa MJ, Just AC, Guerra MS, Kloog I, Hsu HL, Brennan KJ, Garcia AM, Coull B, Wright RJ, Tellez Rojo MM, Baccarelli AA, Wright RO. Identifying sensitive windows for prenatal particulate air pollution exposure and mitochondrial DNA content in cord blood. Environ Int. 2017 Jan;98:198-203. doi: 10.1016/j.envint.2016.11.007. Epub 2016 Nov 11. PubMed 27843010 ↗
  • Renzetti S, Just AC, Burris HH, Oken E, Amarasiriwardena C, Svensson K, Mercado-Garcia A, Cantoral A, Schnaas L, Baccarelli AA, Wright RO, Tellez-Rojo MM. The association of lead exposure during pregnancy and childhood anthropometry in the Mexican PROGRESS cohort. Environ Res. 2017 Jan;152:226-232. doi: 10.1016/j.envres.2016.10.014. Epub 2016 Oct 28. PubMed 27810680 ↗
  • Burris HH, Baccarelli AA, Byun HM, Cantoral A, Just AC, Pantic I, Solano-Gonzalez M, Svensson K, Tamayo y Ortiz M, Zhao Y, Wright RO, Tellez-Rojo MM. Offspring DNA methylation of the aryl-hydrocarbon receptor repressor gene is associated with maternal BMI, gestational age, and birth weight. Epigenetics. 2015;10(10):913-21. doi: 10.1080/15592294.2015.1078963. Epub 2015 Aug 7. PubMed 26252179 ↗
  • Sanders AP, Burris HH, Just AC, Motta V, Svensson K, Mercado-Garcia A, Pantic I, Schwartz J, Tellez-Rojo MM, Wright RO, Baccarelli AA. microRNA expression in the cervix during pregnancy is associated with length of gestation. Epigenetics. 2015;10(3):221-8. doi: 10.1080/15592294.2015.1006498. PubMed 25611922 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03420872
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Sep 15, 2006
Primary completion
Aug 15, 2018
Completion
Aug 15, 2018
Last update
Oct 14, 2019

Study contacts

Robert Wright, MD, MPH
principal investigator · Icahn School of Medicine at Mount Sinai
Mara Tellez-Rojo, PhD
principal investigator · National Institute of Public Health, Mexico

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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