NeurodevelopmentNCT03420872
Nutrient Mixtures and Neurodevelopment
An observational study of Neurodevelopment, run by Icahn School of Medicine at Mount Sinai at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Neurodevelopment
- What is being tested?
- Nutrient mixtures
- How many people
- 329 participants
- Where
- 1 siteMexico
- Study dates
- 15 Sep 2006to 15 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Women of children:
- free of heart or kidney disease
- not use steroids or anti-epilepsy drugs
- not consume alcohol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Neurodevelopment
- Being tested
- Nutrient mixtures
- Keywords
- Nutrition, Nutrients, Mixtures, Neurodevelopment, Prenatal, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrient mixturesOther
consumption of a mixture of beneficial nutrients
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nutrient mixtures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at age 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start15 Sep 2006
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NeurodevelopmentStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wright, MD, MPH, Principal investigator, Icahn School of Medicine at Mount SinaiMara Tellez-Rojo, PhD, Principal investigator, National Institute of Public Health, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420872
- Sponsor's protocol ID
- GCO 12-1417
- Status last verified
- Oct 2019
- First submitted
- 29 Jan 2018
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28728787Rodosthenous 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 27923585Rosa 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 27843010Renzetti 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 27810680Burris 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 26252179Sanders 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal and Childhood Nutrient Mixtures Predict Neurodevelopmental Outcomes Among Children in Mexico City
- ClinicalTrials.gov ID
- NCT03420872
- Acronym / sponsor ID
- GCO 12-1417
- Conditions
- Neurodevelopment
- Keywords
- Nutrition, Nutrients, Mixtures, Neurodevelopment, Prenatal, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 15 Sep 2006 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subset from PROGRESS cohort | – | Other: Nutrient mixturesParticipants 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 |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- free of heart or kidney disease
- not use steroids or anti-epilepsy drugs
- not consume alcohol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrient mixturesconsumption of a mixture of beneficial nutrients | Other | Subset from PROGRESS cohort |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Background: PubMed 28728787Munoz-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.
- Background: PubMed 27923585Rodosthenous 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.
- Background: PubMed 27843010Rosa 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.
- Background: PubMed 27810680Renzetti 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.
- Background: PubMed 26252179Burris 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.
- Background: PubMed 25611922Sanders 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopment, run by Icahn School of Medicine at Mount Sinai at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McCarthy Scales of Children's Abilities (MSCA) (time frame: at age 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420872, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.