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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03420872
Other study ID # GCO 12-1417
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2006
Est. completion date August 15, 2018

Study information

Verified date October 2019
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 329
Est. completion date August 15, 2018
Est. primary completion date August 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 44 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Nutrient mixtures
consumption of a mixture of beneficial nutrients

Locations

Country Name City State
Mexico National Institute of Public Health Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

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, Téllez-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. — View Citation

Muñoz-Rocha TV, Tamayo Y Ortiz M, Romero M, Pantic I, Schnaas L, Bellinger D, Claus-Henn B, Wright R, Wright RO, Téllez-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. — View Citation

Renzetti S, Just AC, Burris HH, Oken E, Amarasiriwardena C, Svensson K, Mercado-García A, Cantoral A, Schnaas L, Baccarelli AA, Wright RO, Téllez-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. — View Citation

Rodosthenous RS, Burris HH, Svensson K, Amarasiriwardena CJ, Cantoral A, Schnaas L, Mercado-García A, Coull BA, Wright RO, Téllez-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. — View Citation

Rosa MJ, Just AC, Guerra MS, Kloog I, Hsu HL, Brennan KJ, García AM, Coull B, Wright RJ, Téllez 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at age 4
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