Clinical trial NCT03420872: Nutrient Mixtures and Neurodevelopment
Official title: Prenatal and Childhood Nutrient Mixtures Predict Neurodevelopmental Outcomes Among Children in Mexico City
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopment
Keywords: Nutrition
Nutrients
Mixtures
Neurodevelopment
Prenatal
Children
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: McCarthy Scales of Children's Abilities (MSCA)
timeFrame: at age 4
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Public Health
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Robert Wright, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Public Health, Mexico
name: Mara Tellez-Rojo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.