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Effect of zinc and omega-3 supplements in children with attention-deficit hyperactivity disorder

Protocol summary

Summary
To determine the effect of supplemental zinc and omega-3 as adjuvant therapy on children with ADHD. The study is designed as a randomized clinical trial with a placebo group. Inclusion criteria: 1. Age: 6-15 years, 2. Newly diagnosed patient, 3. No history of taking any psychiatric drug, 4. No other psychiatric disorders, 5. There is no contraindication for the use of zinc and omega 3, 6. Diagnosis of ADHD is based on diagnostic criteria in DSM IV and diagnostic interview of psychiatrist. Exclusion criteria: 1. Parents or children withdrew the study because of any reason, 2. Child is suffering from acute physical illness, 3. Children can’t use oral drugs, 4. Complications of drugs is so high that we have to stop them, 5. Alter treatment, 6. The drug is not used, 7. Any previous psychiatric disorders, 8. Mental retardation, 9. The patient can’t use drugs. The total number of cases is 150 patients.The Patients will classify in three equal groups as A, B or C randomly. A group of children will receive placebo and Ritalin daily. B group will receive Zinc supplement and Ritalin daily. C group will receive omega-3 supplement and Ritalin daily. All children will treat for 8 weeks after treatment. 48 questions Conner's Rating Scals questionnaire of parents will complete at 2 weeks, 4 weeks and 8 weeks after starting treatment in the presence of the researcher. 48 questions Conner's Rating Scals questionnaire of teachers will complete after explanations by the researcher.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104166201N1
Registration date: 2011-05-13, 1390/02/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-05-13, 1390/02/23
Registrant information
Name
Hamid Sheykholeslami
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 4715
Email address
hamid.sh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Education and Research of Arak University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc and omega-3 supplements in children with attention-deficit hyperactivity disorder
Public title
Effect of zinc and omega-3 supplements as adjuvant therapy in children with attention-deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Age: 6-15 years, 2. Newly diagnosed patient, 3. No history of taking any psychiatric drug, 4. No other psychiatric disorders, 5. There is no contraindication for the use of zinc and omega 3, 6. Diagnosis of ADHD is based on diagnostic criteria in DSM IV and diagnostic interview of psychiatrist. Exclusion criteria: 1. Parents or children withdrew the study because of any reason, 2. Child is suffering from acute physical illness, 3. Children can’t use oral drugs, 4. Complications of drugs is so high that we have to stop them, 5. Alter treatment, 6. The drug is not used, 7. Any previous psychiatric disorders, 8. Mental retardation, 9. The patient can’t use drugs.
Age
From 6 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Shahid shiroodi Ave. Alamolhoda st.
City
Arak
Postal code
3819693345
Approval date
2011-02-14, 1389/11/25
Ethics committee reference number
89-100-90

Health conditions studied

1

Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Hyperkinetic disorders

Primary outcomes

1

Description
Scores in questionnaire
Timepoint
before treatment and then 2 weeks, 4 and 8 weeks after treatment
Method of measurement
48 questions Conner's Rating Scals questionnaire

Secondary outcomes

1

Description
Adverse reactions
Timepoint
2 weeks, 4 weeks and 8 weeks after treatment
Method of measurement
drug adverse reactions questionnaire

Intervention groups

1

Description
Children will receive omega-3 supplement and Ritalin in the third group. Dose of omega-3 supplement is based on the weight of the child as follows: children less than 25 kg ,100 mg of EPA children between 26 to 35 kg ,200 mg of EPA and children above 36 kg , 400 mg of EPA.
Category
Treatment - Drugs

2

Description
Children will receive placebo with Ritalin in the first group.
Category
Placebo

3

Description
Children will receive Zinc supplement 15mg daily and placebo in the second group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Amir Kabir haspital
Full name of responsible person
Dr. Fatemh Dorreh
Street address
Alamol-hoda st.
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Education and Research of Arak University of Medical Sciences
Full name of responsible person
Dr. Saeed Changizi Ashtiani
Street address
Pardis educational complex, Basij square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Education and Research of Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Dorreh
Position
Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir hospital, Alamol-hoda st.
City
Arak
Postal code
Phone
+98 86 1313 4715
Fax
Email
fatemeh_dorre@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Bahman Salehi
Position
Associate Professor
Other areas of specialty/work
Street address
Amir Kabir hospital, Alamol-hoda st.
City
Arak
Postal code
Phone
+98 86 1313 4715
Fax
+98 86 1313 2510
Email
basalehi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Hamid Sheykholeslami
Position
Resident
Other areas of specialty/work
Street address
Amir Kabir hospital, Alamol-hoda st.
City
Arak
Postal code
Phone
+98 86 1313 4715
Fax
+98 86 1313 2510
Email
sheykholeslamih@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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