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Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren

This study has been completed.
National Institute of Mental Health (NIMH)
Institute of Nutrition of Central America and Panama (INCAP)
Mexican National Institute of Public Health
Information provided by (Responsible Party):
Aryeh David Stein, Emory University Identifier:
First received: January 26, 2006
Last updated: November 16, 2015
Last verified: November 2015
This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala.

Condition Intervention
Dietary Supplement: 10 mg zinc oxide
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Zinc, Mental Health, and School Performance

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Symptoms of depression [ Time Frame: Baseline and post supplementation ]

Secondary Outcome Measures:
  • Symptoms of anxiety [ Time Frame: Baseline and post supplementation ]
  • attention problems and school performance [ Time Frame: Baseline and post supplementation ]
  • activity levels [ Time Frame: Baseline and post supplementation ]
  • zinc levels [ Time Frame: Baseline and post supplementation ]

Enrollment: 750
Study Start Date: January 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00283660

Instituto de Nutrición de Centro América y Panamá - INCAP
Guatemala City, Guatemala, 01011
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Institute of Nutrition of Central America and Panama (INCAP)
Mexican National Institute of Public Health
Principal Investigator: Aryeh D Stein, PhD Emory University
  More Information

Responsible Party: Aryeh David Stein, Professor, Global Health, Emory University Identifier: NCT00283660     History of Changes
Other Study ID Numbers: IRB00045755
R01MH067981 ( US NIH Grant/Contract Award Number )
Study First Received: January 26, 2006
Last Updated: November 16, 2015

Keywords provided by Emory University:
Dietary Supplements
Nutritional Supplements
Mental Health

Additional relevant MeSH terms:
Zinc Oxide
Trace Elements
Growth Substances
Physiological Effects of Drugs
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents processed this record on May 22, 2017