Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren

November 16, 2015 updated by: Aryeh David Stein, Emory University

Zinc, Mental Health, and School Performance

This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mental health problems are an important cause of dysfunction throughout the world, accounting for 8.1% of the Global Burden of Disease. The need for interventions that can prevent mental health conditions, particularly among children, cannot be overemphasized. This study will determine whether zinc supplementation improves the mental health and school performance among children in Guatemala.

Participants will be randomly assigned to receive daily supplements of either zinc or placebo for 6 months. Participants will be assessed at study entry and after the 6-month treatment. Participants and their parents and teachers will complete questionnaires about the participants' symptoms of depression and anxiety, concentration and activity levels, school performance, and any environmental stressors to which the participants may be exposed to.

Study Type

Interventional

Enrollment (Actual)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • Guatemala City, Guatemala, 01011
        • Instituto de Nutrición de Centro América y Panamá - INCAP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Attend a public school in specific Guatemalan community and has thorough and up-to-date school records
  • Currently in 2nd to 6th grade
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • Any illness that may affect participants' zinc levels
  • Any chronic illness
  • History of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active
Dietary Supplement: 10 mg zinc oxide
Dietary supplement: 10 mg zinc oxide
10 mg zinc oxide
PLACEBO_COMPARATOR: Placebo
Placebo (double blinded)
Other: Placebo
Placebo pill taken five days a week for six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms of depression
Time Frame: Baseline and post supplementation
Baseline and post supplementation

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptoms of anxiety
Time Frame: Baseline and post supplementation
Baseline and post supplementation
attention problems and school performance
Time Frame: Baseline and post supplementation
Baseline and post supplementation
activity levels
Time Frame: Baseline and post supplementation
Baseline and post supplementation
zinc levels
Time Frame: Baseline and post supplementation
Baseline and post supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Mental Health (NIMH)
Mexican National Institute of Public Health
Institute of Nutrition of Central America and Panama (INCAP)

Investigators

  • Principal Investigator: Aryeh D Stein, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (ESTIMATE)

January 30, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00045755
  • DSIR 84-CTM
  • R01MH067981 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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