DepressionNCT00283660
Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren
A study testing 10 mg zinc oxide in people with Depression and Anxiety, run by Emory University at 1 site in Guatemala.
Trial summary
This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- 10 mg zinc oxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 1 siteGuatemala
- Study dates
- Jan 2006to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Any illness that may affect participants' zinc levels
- Any chronic illness
- History of cancer
Trial locations and contacts
1 site in 1 country.
Guatemala1 site
Instituto de Nutrición de Centro América y Panamá - INCAP
Guatemala City, 01011
About this study
Official title: Zinc, Mental Health, and School Performance
This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- 10 mg zinc oxide, Placebo
- Keywords
- Zinc, Dietary Supplements, Nutritional Supplements, Child, Mental Health, School, Guatemala
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg zinc oxideDietary supplement
10 mg zinc oxide
PlaceboOther
Placebo pill taken five days a week for six months.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Dietary Supplement: 10 mg zinc oxide Receives: Dietary Supplement: 10 mg zinc oxide |
| Placebo | Placebo comparator | Placebo (double blinded) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of depression
Measured: Baseline and post supplementation
Secondary outcomes (4)
Symptoms of anxiety
Measured: Baseline and post supplementation
attention problems and school performance
Measured: Baseline and post supplementation
activity levels
Measured: Baseline and post supplementation
zinc levels
Measured: Baseline and post supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Institute of Nutrition of Central America and Panama, Mexican National Institute of Public Health
- Responsible party
- Principal investigator, Aryeh David Stein, Emory University
- Investigators
- Aryeh D Stein, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283660
- Sponsor's protocol ID
- IRB00045755
- Other IDs
- R01MH067981, DSIR 84-CTM
- Status last verified
- Nov 2015
- First submitted
- 26 Jan 2006
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20881069Bui 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.
PubMed 22354676
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc, Mental Health, and School Performance
- ClinicalTrials.gov ID
- NCT00283660
- Acronym / sponsor ID
- IRB00045755
- Conditions
- Depression, Anxiety
- Keywords
- Zinc, Dietary Supplements, Nutritional Supplements, Child, Mental Health, School, Guatemala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Institute of Nutrition of Central America and Panama, Mexican National Institute of Public Health
- Study start
- Jan 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 30 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Dietary Supplement: 10 mg zinc oxideDietary Supplement: 10 mg zinc oxide |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (double blinded) |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Any illness that may affect participants' zinc levels
- Any chronic illness
- History of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 mg zinc oxide10 mg zinc oxide | Dietary supplement | Active |
| PlaceboPlacebo pill taken five days a week for six months. | Other | Placebo |
Primary outcome
Symptoms of depression
Time frame: Baseline and post supplementation
4 secondary outcomes
Symptoms of anxiety
Time frame: Baseline and post supplementation
attention problems and school performance
Time frame: Baseline and post supplementation
activity levels
Time frame: Baseline and post supplementation
zinc levels
Time frame: Baseline and post supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Results publication: PubMed 20881069DiGirolamo 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.
- Results publication: PubMed 22354676Bui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aryeh D Stein, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 mg zinc oxide in people with Depression and Anxiety, run by Emory University at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of depression (time frame: Baseline and post supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283660, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.