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Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren

Emory University logo

Emory University

Status

Completed

Conditions

Depression
Anxiety

Treatments

Other: Placebo
Dietary Supplement: 10 mg zinc oxide

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00283660
IRB00045755
DSIR 84-CTM
R01MH067981 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

750 patients

Sex

All

Ages

7 to 11 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

750 participants in 2 patient groups, including a placebo group

Active
Experimental group
Description:
Dietary Supplement: 10 mg zinc oxide
Treatment:
Dietary Supplement: 10 mg zinc oxide
Placebo
Placebo Comparator group
Description:
Placebo (double blinded)
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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