Clinical trial NCT00283660: Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren
Official title: Zinc, Mental Health, and School Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Zinc
Dietary Supplements
Nutritional Supplements
Child
Mental Health
School
Guatemala
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Institute of Nutrition of Central America and Panama (INCAP)
name: Mexican National Institute of Public Health
First posted: 2006-01-30
Enrollment: 750
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: Symptoms of depression
timeFrame: Baseline and post supplementation
Secondary outcomes:
measure: Symptoms of anxiety
timeFrame: Baseline and post supplementation
measure: attention problems and school performance
timeFrame: Baseline and post supplementation
measure: activity levels
timeFrame: Baseline and post supplementation
measure: zinc levels
timeFrame: Baseline and post supplementation
Other outcomes:
Locations:
city: Guatemala City
country: Guatemala
facility: Instituto de Nutrición de Centro América y Panamá - INCAP
Study officials:
affiliation: Emory University
name: Aryeh D Stein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bui 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.