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 range18 Years – 35 Years

SexFEMALE

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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

What they're measuring

Autism spectrum disorder

Timeframe: From 16 to 20 months of age

Trial details

NCT IDNCT04983667

SponsorInstituto Tecnologico y de Estudios Superiores de Monterey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31