Zinc-AA Supplementation During Pregnancy & Lactation to Assess Effects on ASD Prevalence in Offsp… (NCT04983667) | Clinical Trial Compass
TerminatedNot Applicable
Zinc-AA Supplementation During Pregnancy & Lactation to Assess Effects on ASD Prevalence in Offspring
Stopped: A funding agreement could not be secured with the primary funding organizations
Mexico109 participantsStarted 2021-05-27
Plain-language 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
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Autism spectrum disorder
Timeframe: From 16 to 20 months of age
Trial details
NCT IDNCT04983667
SponsorInstituto Tecnologico y de Estudios Superiores de Monterey