Autism Spectrum DisorderNCT04983667
Zinc-AA Supplementation During Pregnancy & Lactation to Assess Effects on ASD Prevalence in Offspring
A study testing Zn-AA in people with Autism Spectrum Disorder and Zinc Deficiency, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Zinc Deficiency, Pregnancy Related
- What is being tested?
- Zn-AA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteMexico
- Study dates
- 27 May 2021to 23 Jan 2023
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Universitario en Salud
San Nicolás de los Garza, Nuevo León, 64451
About this study
Official title: 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
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
Read the 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).
- Conditions
- Autism Spectrum Disorder, Zinc Deficiency, Pregnancy Related
- Being tested
- Zn-AA
- Keywords
- Zinc supplementation, Pregnancy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zn-AADietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Orange | Experimental | Zinc-AA, Tablet, 30 mg. PO, Once Daily for up to one year Receives: Dietary Supplement: Zn-AA |
| Green | Placebo comparator | Placebo, Tablet, 30 mg. PO, Once Daily for up to one year. Receives: Dietary Supplement: Zn-AA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism spectrum disorder
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.
Measured: From 16 to 20 months of age
Secondary outcomes (2)
Microbiota modification associated to maternal zinc supplementation or placebo during pregnancy
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
Measured: From birth to six months of age
Immune phenotype
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
Measured: From birth to six months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start27 May 2021
- Primary completion31 Dec 2022
- Study completion23 Jan 2023
Why it stopped: A funding agreement could not be secured with the primary funding organizations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel 1:1 randomization to one of two interventions, the active compound or the placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Javier Lara-Diaz, M.D., Ph.D., Instituto Tecnologico y de Estudios Superiores de Monterey
- Investigators
- Rebeca Thelma Martínez-Villarreal, M.D., Ph:D., Principal investigator, Universidad Autónoma de Nuevo León, Centro Universitario de Salud, Campus de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983667
- Sponsor's protocol ID
- Zinc-Autismo
- Status last verified
- Mar 2024
- First submitted
- 11 Jul 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be archived in the Institutional Repository
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04983667
- Acronym / sponsor ID
- Zinc-Autismo
- Conditions
- Autism Spectrum Disorder, Zinc Deficiency, Pregnancy Related
- Keywords
- Zinc supplementation, Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A funding agreement could not be secured with the primary funding organizations
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 30 Jul 2021 (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.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel 1:1 randomization to one of two interventions, the active compound or the placebo
| Arm | Type | Receives |
|---|---|---|
| Orange | Experimental | Dietary Supplement: Zn-AAZinc-AA, Tablet, 30 mg. PO, Once Daily for up to one year |
| Green | Placebo comparator | Dietary Supplement: Zn-AAPlacebo, Tablet, 30 mg. PO, Once Daily for up to one year. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Zn-AAOral 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. | Dietary supplement | Green, Orange |
Primary outcome
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.
2 secondary outcomes
Microbiota modification associated to maternal zinc supplementation or placebo during pregnancy
Time frame: From birth to six months of age
Immune phenotype
Time frame: From birth to six months of age
Results and safety
The study was stopped early (reason given: A funding agreement could not be secured with the primary funding organizations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Yes. Data will be archived in the Institutional Repository
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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.
Rebeca Thelma Martínez-Villarreal, M.D., Ph:D. principal investigator
Universidad Autónoma de Nuevo León, Centro Universitario de Salud, Campus de la Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zn-AA in people with Autism Spectrum Disorder and Zinc Deficiency, run by Instituto Tecnologico y de Estudios Superiores de Monterey 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Mar 2024. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: A funding agreement could not be secured with the primary funding organizations). Results are not available in the source record.
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?
Autism spectrum disorder (time frame: From 16 to 20 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.