- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04983667
Zinc-AA Supplementation During Pregnancy & Lactation to Assess Effects on ASD Prevalence in Offspring
Supplementation of Zinc-AA Complexes in Women During Pregnancy and Lactation, to Assess Effects on Autism Spectrum Disorder (ASD), Immune Status and Gut Microbiota in Offspring
Study Overview
Status
Intervention / Treatment
Detailed Description
Autism and associated disorders (Autism Spectrum Disorders, ASD) is the fastest growing disability in the world, statistics indicate a prevalence of between 1 and 3%. This entity is the one that generates more stress in families, four times more than in a neuro-typical family and twice more than in a family with any other disability. Besides, this condition increases health spending for the family, the state and the country.
By not knowing the cause, and witnessing the growth of this disability, with the prevalence described, and the births reported in 2019 in Mexico (2,092,214), we expect between 20,922 and 62,766 new cases in our country each year. In Nuevo León, a state in the northeast of Mexico, the average birth rate per year from 2017 to 2019 (latest official data available) is 91,484, which makes us estimate an incidence of 915 to 2744, for the same period. ASD is also a family stressful disability, associated to a high rate of separations, social isolation and divorces, which leads to social problems of alarming dimensions. In the United States, for 2025 the cost of Autism is projected at 1 trillion dollars, associated with medications, interventions and educational expenses.
In Mexico, the lack of universal diagnostic screening, detection and intervention programs before the age of three years makes those affected to require important support throughout their lives, since the benefits of early intervention are lost.
This project consists of two parts. The first is the Primary Study. It consists of establishing whether the supplementation of Zinc-AA complexes, in women during pregnancy and lactation, has any effect on the prevalence of Autism and if it favorably modifies the immunological and metabolic status of the mother and the progeny; seeks to confirm the findings that our group of investigators has obtained in published pre-clinical investigations that found that a Zinc deficiency in the mother (mice and human erythrocytes), caused by dietary factors, provokes changes in the morphology of the intestine of the progeny, as well as modifications in the microbiota and increased inflammatory markers in the blood and brain, similar to those reported in people with Autism. In Latin America, the diet is based on cereals, and i so abundant in dietary fiber and phytates. These factors, along supplements usually recommended to mothers who plan to become pregnant (Calcium, Iron and Folic Acid), predispose these women to Zinc deficiency. We are also proposing a Secondary Study, to establish the zinc status and the characteristics of the intestinal microbiome in young, non-pregnant adult women, as a comparative reference standard.
Until now, there are no projects in the world that seek to partially or totally solve the causes of Autism, this is the first study that seeks to prevent the problems associated with autism and could be the first to influence the reduction of the incidence of Autism. This project will involve Mexican researchers from Instituto Tecnologico y de Estudios Superiores de Monterrey (ITESM), as well as researchers from the University of Limerick, Ireland, from the University Clinic of the Autonomous University of Nuevo León, in the northeast of Mexico; as well as the Laboratory of Dr. Fanis Missirlis, of the National Polytechnic Institute, in Mexico City.
This project has the financial support of the International Zinc Association (IZA), managed by Zinpro Corp., represented in Mexico by Elemend Salud, representative Ing. Guillermo Vela Staines (g.vela@zinpro.com).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Victor Javier Lara-Díaz, M.D., Ph. D.
- Phone Number: +52 81 8366 5170
- Email: lara-diaz.vj@tec.mx
Study Contact Backup
- Name: Georgina Pérez-Liz, M.D, Ph. D.
- Phone Number: 215 571 3431
- Email: gmp69@drexel.edu
Study Locations
-
-
Nuevo Leon
-
San Nicolás De Los Garza, Nuevo Leon, Mexico, 64451
- Centro Universitario en Salud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women from 18 to 35 years of age, pregnant, within the 12th and 20th week (Primary study) or with the intention to get pregnant in the following six months (Secondary study)
- Hemoglobin over 8 g/dL
- Accepting to be included in a standard pediatric physical and neurobehavioral follow-up program from birth and to at least 18 months of age.
- Accepting to receive the Zinc supplement (or placebo) and to ingest it daily from the inclusion to the study and up to the sixth postnatal month
- Agreement to read and sign the Informed Consent Document
Exclusion Criteria:
- Women who do not accept to deliver in a hospital setting, or without immediate access to a proper facility
- Women with self-reported alcohol or drug addiction
- Women with a sero positivity to HIV, even if under treatment
- Women with a pregnancy resulted from assisted or in vitro fertilization techniques
- Women with an active severe acute respiratory syndrome-Coronavirus (SARS-CoV2) infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Orange
Zinc-AA, Tablet, 30 mg.
PO, Once Daily for up to one year
|
Oral supplementation of either 30 mg daily or Zinc-AA complex or placebo, from the study recruitment during first trimester of pregnancy, all through pregnancy and up to the sixth month after giving birth.
|
Placebo Comparator: Green
Placebo, Tablet, 30 mg.
PO, Once Daily for up to one year.
|
Oral supplementation of either 30 mg daily or Zinc-AA complex or placebo, from the study recruitment during first trimester of pregnancy, all through pregnancy and up to the sixth month after giving birth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autism spectrum disorder
Time Frame: From 16 to 20 months of age
|
Positive identification of any component of the Autism Spectrum Disorder (ASD) through the Autism Diagnosis Observation Schedule, 2nd edition (ADOS-2) specialized battery of tests, which provide a standardized set of tests that offer as output a set of ranges of concern reflecting the extent to which a child demonstrates behaviors associated with ASD.
|
From 16 to 20 months of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiota modification associated to maternal zinc supplementation or placebo during pregnancy
Time Frame: From birth to six months of age
|
Comparative analysis of the microbiome composition (Type and relative quantity of micro-organisms) in a subset of the supplemented and the un-supplemented groups, at birth, and also at the end of the first six months of lactation
|
From birth to six months of age
|
Immune phenotype
Time Frame: From birth to six months of age
|
Comparison of the Immune phenotype (Type and quantity of main Interleukines and Cytokines in peripheral blood, and characterization of Leucocyte population and subpopulation, also in peripheral blood) in a subset of the supplemented and the un-supplemented groups, at birth, and also at the end of the first six months of lactation
|
From birth to six months of age
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rebeca Thelma Martínez-Villarreal, M.D., Ph:D., Universidad Autónoma de Nuevo León, Centro Universitario de Salud, Campus de la Salud
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Zinc-Autismo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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