Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH067981 | U.S. NIH Grant/Contract | View source | |
| DSIR 84-CTM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Institute of Nutrition of Central America and Panama | OTHER |
| Mexican National Institute of Public Health | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Dietary Supplement: 10 mg zinc oxide |
|
| Placebo | Placebo Comparator | Placebo (double blinded) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 mg zinc oxide | Dietary Supplement | 10 mg zinc oxide |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of depression | Baseline and post supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of anxiety | Baseline and post supplementation | |
| attention problems and school performance | Baseline and post supplementation | |
| activity levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aryeh D Stein, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Nutrición de Centro América y Panamá - INCAP | Guatemala City | 01011 | Guatemala |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20881069 | Result | 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. | |
| 22354676 | Result | 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. |
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
Not provided
Not provided
| ID | Term |
|---|---|
| D015034 | Zinc Oxide |
| ID | Term |
|---|---|
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D007287 | Inorganic Chemicals |
| D017967 | Zinc Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Placebo pill taken five days a week for six months. |
|
| Baseline and post supplementation |
| zinc levels | Baseline and post supplementation |