Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren

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

Detailed Description
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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.

Official Title
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Zinc, Mental Health, and School Performance

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Dietary Supplement: 10 mg zinc oxide
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Dietary Supplement: 10 mg zinc oxide | Dietary Supplement: 10 mg zinc oxide<br>* 10 mg zinc oxide<br>|
| Placebo Comparator: Placebo<br>Placebo (double blinded) | Other: Placebo<br>* Placebo pill taken five days a week for six months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of depression |  | Baseline and post supplementation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc, Dietary Supplements, Nutritional Supplements, Child, Mental Health, School, Guatemala