Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren

Not Applicable

Completed

• Conditions: Depression; Anxiety
• Interventions: Other: Placebo; Dietary Supplement: 10 mg zinc oxide

• Registration Number: NCT00283660
• Lead Sponsor: Emory University

Brief Summary

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

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-30
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (double blinded)
Active	10 mg zinc oxide	Dietary Supplement: 10 mg zinc oxide

Primary Outcome Measures

Name	Time	Method
Symptoms of depression	Baseline and post supplementation

Secondary Outcome Measures

Name	Time	Method
attention problems and school performance	Baseline and post supplementation
zinc levels	Baseline and post supplementation
Symptoms of anxiety	Baseline and post supplementation
activity levels	Baseline and post supplementation

Trial Locations

Locations (1)

Instituto de Nutrición de Centro América y Panamá - INCAP; 🇬🇹 Guatemala City, Guatemala