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Completed

NCT Number: NCT00283660

Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren

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

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Nutrición de Centro América y Panamá - INCAP

Guatemala City, 01011, Guatemala

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 mg zinc oxide

Dietary Supplement

10 mg zinc oxide

Placebo

Other

Placebo pill taken five days a week for six months.

Primary outcomes

  1. Symptoms of depression

    Time frame: Baseline and post supplementation

Secondary outcomes

  1. Symptoms of anxiety

    Time frame: Baseline and post supplementation

  2. attention problems and school performance

    Time frame: Baseline and post supplementation

  3. activity levels

    Time frame: Baseline and post supplementation

  4. zinc levels

    Time frame: Baseline and post supplementation

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

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

Registry information

Official study title

Zinc, Mental Health, and School Performance

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 30, 2006
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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