Determining the effect of diet on symptoms of quality of life, disability, cognitive and academic performance of children with attention deficit hyperactivity disorder
Design
This study will be conducted as a phase 3 clinical trial with a control group on children with attention deficit hyperactivity disorder. The study is single blind and will be conducted on 44 patients. The rand function of Excel software will be used for randomization
Settings and conduct
The participants are ADHD patiens under care in the children's department of Besat Hospital of Hamedan, who will be randomly assigned to intervention and control groups, the intervention group will be take atomoxetine drug with a diet containing vitamins of group B and vitamins C and iron and zinc minerals. The control group will receive Atomoxetine drug without nutritional intervention. Both groups will be followed for 8 months. Disease symptoms in two groups before and after the intervention will be evaluated with SWAN, Conners and SDQ questionnaires. The person who evaluating the symptoms at the end of the treatment will be blinded of the intervention and control groups.
Participants/Inclusion and exclusion criteria
The participants are 7-16-year-old children with attention-deficit-hyperactivity disorder who have a normal IQ. Children with neurological or organic disorders will not be included in the study
Intervention groups
The intervention group will be treated with 40 mg atomoxetine daily and a diet containing essential amino acids, vitamin groups and vitamin C, and iron and zinc minerals. The control group will only use atomoxetine 40 mg daily and the usual daily diet
Main outcome variables
The main outcome of studying will be the changes in the clinical symptoms of attention deficit hyperactivity disorder in the fields of quality of life, disability, cognitive and academic performance.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N25
Registration date:2022-12-15, 1401/09/24
Registration timing:prospective
Last update:2022-12-15, 1401/09/24
Update count:0
Registration date
2022-12-15, 1401/09/24
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of diets on symptom control of attention deficit hyperactivity disorder in children
Public title
The effect of diet on the symptoms of attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 7 to 16 years
No neurological or organic disorder
Exclusion criteria:
Lack of compliance
Patients on a special diet
Age
From 7 years old to 16 months old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
We made 44 cards and write letter I on 22 for intervention and on the other 22 letter C for the Control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter ( I or C) patients will be assigned to intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the symptoms of attention-deficit/hyperactivity disorder after the intervention will be blinded of the type of treatment regimen of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
ُُHamadan University of medical Science, Shahid Fahmideh Ave, Hamadan city, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.UMSHA.REC.140.756
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Change in disease symptoms
Timepoint
Before starting treatment and 8 months after starting treatment
Method of measurement
with the SWAN and Conners questionnaires
Secondary outcomes
1
Description
Changes in the child's strengths and weaknesses
Timepoint
Before and 8 months after treatment starting
Method of measurement
with the SDQ questionnaire
Intervention groups
1
Description
Intervention group: Underwent atomoxetine (40 mg daily) and diet including essential amino acids, B vitamins, vitamin C and iron and zinc minerals Treatment
Category
Treatment - Other
2
Description
Control group: Treated with atomoxetine 40 mg without special diet
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Afshin Faiazi
Street address
Besat hospital, Shahid Beheshti Blv, Hamadan city, Iran
City
Hamadan
Province
Hamadan
Postal code
6515974544
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokohi
Street address
Hamadan University of medical science, Shahid Fahmide Ave, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
shahid fahmideh street medical faculty
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Afshin Faiazi
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Medical school, Shahid Fahmideh Ave, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
Afshinfay@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medical School, Shahid Fahmideh Ave, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available