Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04983667 |
| Other study ID # |
Zinc-Autismo |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 27, 2021 |
| Est. completion date |
January 23, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Instituto Tecnologico y de Estudios Superiores de Monterey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Autism and associated entities, grouped under the Autism Spectrum Disorders (ASD) is the
fastest growing intellectual disability in the world, statistics signal for a 1 to 3%
prevalence on infants. The cause is unknown, although some data suggest that zinc deficiency
during pregnancy may have an important role in its presentation. This study seeks to
supplement the nutrition of randomly selected prospective and actually pregnant women with a
zinc-Amino-acid complex (Zn-AA), during pregnancy and early lactation, and compare the rate
of ASD in their offspring with the rate in a similar and also randomly selected cohort of non
supplemented women, to assess if Zn-AA supplementation during pregnancy has any effect on
this outcome
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).
