Zinc-AA Supplementation During Pregnancy & Lactation to Assess Effects on ASD Prevalence in Offspring

NCT04983667 | Terminated DMC

• 1 other identifier: Zinc-Autismo
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Autism Spectrum Disorder; Zinc Deficiency; Pregnancy Related

Keywords

Zinc supplementation; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

  From 16 to 20 months of age

Secondary Outcomes (2)

• Microbiota modification associated to maternal zinc supplementation or placebo during pregnancy

  From birth to six months of age

• Immune phenotype

  From birth to six months of age

Study Arms (2)

Orange

EXPERIMENTAL

Zinc-AA, Tablet, 30 mg. PO, Once Daily for up to one year

Dietary Supplement: Zn-AA

Green

PLACEBO COMPARATOR

Placebo, Tablet, 30 mg. PO, Once Daily for up to one year.

Dietary Supplement: Zn-AA

Interventions

Zn-AA DIETARY_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.

Green; Orange

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Agreement to read and sign the Informed Consent Document

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Tecnologico y de Estudios Superiores de Monterey: lead

Study Sites (1)

Centro Universitario en Salud

San Nicolás de los Garza, Nuevo León, 64451, Mexico

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Rebeca Thelma Martínez-Villarreal, M.D., Ph:D.

  Universidad Autónoma de Nuevo León, Centro Universitario de Salud, Campus de la Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomized allocation to one of two supplements, one has the active compound, the other is a placebo. Identical containers and labels have been designed. Both groups will receive the customary iron sulfate and folic acid supplementation along pregnancy
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Researcher

Model Details: Parallel 1:1 randomization to one of two interventions, the active compound or the placebo

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 30, 2021
• Study Start: May 27, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 23, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year upon completion
• Access Criteria: To qualified health researchers upon request, all data will be anonymized.

Locations

ME (1)