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Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00283660
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : November 17, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Depression Anxiety Dietary Supplement: 10 mg zinc oxide Other: Placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Zinc, Mental Health, and School Performance
Study Start Date : January 2006
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Zinc oxide
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00283660     History of Changes
Other Study ID Numbers: IRB00045755
R01MH067981 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2006    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Aryeh David Stein, 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