Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00283660
First received: January 26, 2006
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Depression
Anxiety
Dietary Supplement: 10 mg zinc oxide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms of anxiety [ Time Frame: Baseline and post supplementation ] [ Designated as safety issue: No ]
  • attention problems and school performance [ Time Frame: Baseline and post supplementation ] [ Designated as safety issue: No ]
  • activity levels [ Time Frame: Baseline and post supplementation ] [ Designated as safety issue: No ]
  • zinc levels [ Time Frame: Baseline and post supplementation ] [ Designated as safety issue: No ]

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 vs sugar placebo pill daily (5 days/wk) for 6 months
Placebo Comparator: Placebo
Placebo (double blinded)

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.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283660

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

Publications:
Responsible Party: Aryeh David Stein, Professor, Global Health, Emory University
ClinicalTrials.gov Identifier: NCT00283660     History of Changes
Other Study ID Numbers: IRB00045755, R01MH067981, DSIR 84-CTM
Study First Received: January 26, 2006
Last Updated: November 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Zinc
Dietary Supplements
Nutritional Supplements
Child
Mental Health
School
Guatemala

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders
Zinc
Zinc Oxide
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Sunscreening Agents
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 31, 2014