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

NCT04983667 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2024-03-06

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Zn-AA

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.

Sponsors & Collaborators

  • Instituto Tecnologico y de Estudios Superiores de Monterey

    lead OTHER

Principal Investigators

  • Rebeca Thelma Martínez-Villarreal, M.D., Ph:D. · Universidad Autónoma de Nuevo León, Centro Universitario de Salud, Campus de la Salud

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2022-12-31
Completion
2023-01-23

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04983667 on ClinicalTrials.gov