Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren
3 other identifiers
interventional
750
1 country
1
Brief Summary
This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jan 2006
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 26, 2006
CompletedFirst Posted
Study publicly available on registry
January 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedNovember 17, 2015
November 1, 2015
9 months
January 26, 2006
November 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptoms of depression
Baseline and post supplementation
Secondary Outcomes (4)
Symptoms of anxiety
Baseline and post supplementation
attention problems and school performance
Baseline and post supplementation
activity levels
Baseline and post supplementation
zinc levels
Baseline and post supplementation
Study Arms (2)
Active
EXPERIMENTALDietary Supplement: 10 mg zinc oxide
Placebo
PLACEBO COMPARATORPlacebo (double blinded)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any illness that may affect participants' zinc levels
- Any chronic illness
- History of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Nutrición de Centro América y Panamá - INCAP
Guatemala City, 01011, Guatemala
Related Publications (2)
DiGirolamo AM, Ramirez-Zea M, Wang M, Flores-Ayala R, Martorell R, Neufeld LM, Ramakrishnan U, Sellen D, Black MM, Stein AD. Randomized trial of the effect of zinc supplementation on the mental health of school-age children in Guatemala. Am J Clin Nutr. 2010 Nov;92(5):1241-50. doi: 10.3945/ajcn.2010.29686. Epub 2010 Sep 29.
PMID: 20881069RESULTBui VQ, Stein AD, DiGirolamo AM, Ramakrishnan U, Flores-Ayala RC, Ramirez-Zea M, Grant FK, Villalpando S, Martorell R. Associations between serum C-reactive protein and serum zinc, ferritin, and copper in Guatemalan school children. Biol Trace Elem Res. 2012 Aug;148(2):154-60. doi: 10.1007/s12011-012-9358-0. Epub 2012 Feb 22.
PMID: 22354676RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aryeh D Stein, PhD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Global Health
Study Record Dates
First Submitted
January 26, 2006
First Posted
January 30, 2006
Study Start
January 1, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
November 17, 2015
Record last verified: 2015-11