Comparison of Mare Milk and Cow Milk in Children With Attention Deficit-Hyperactivity Disorder
Design
This is a double blind crossover randomized clinical trial on children with attention-deficit/hyperactivity disorder. Patients will be chosen between 6 to 14 years old and both sex. Pediatric psychologist will diagnose ADHD patients with connors test.
Settings and conduct
This is a double blind crossover randomized clinical trial on children with attention-deficit/hyperactivity disorder. Pediatric psychologist will diagnose ADHD patients with connors test.
Participants/Inclusion and exclusion criteria
Patients will be chosen between 6 to 14 years old and both sex. Pediatric psychologist will diagnose ADHD patients with Connors test. patients with other psycologic or neurologic comorbidities; predominantly inattentive; history of prematurity or dysmaturity; history of smoking in mother during pregnancy would be the exclusion criteria.
Intervention groups
Patients will experience both of mare milk and cow milk consumption in two 45 days periods. In addition, they will have a 7 days wash out period between to main period. Patients will drink 250 ml milk every day.
Main outcome variables
Connors test will be evaluate before and after each period of milk consumption that will be filled out by parents and teachers. Drug dose, connors score and side effects, height and weight, appetite and sleep qualifications will be record. Primary essential information will be explained for the patients and their parents. Written consent will be obtained from the client and his/her parents , in addition researcher phone number will be given to them for any probable concern or problem. Finally, data will be analyzed by computer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170823035862N1
Registration date:2018-01-16, 1396/10/26
Registration timing:registered_while_recruiting
Last update:2018-01-16, 1396/10/26
Update count:0
Registration date
2018-01-16, 1396/10/26
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3628 9681
Email address
z.jokar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-04-08, 1397/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Mare Milk and Cow Milk in Children with Attention-Deficit/Hyperactivity Disorder
Public title
Comparison of Mare Milk and Cow Milk in Children with Attention-Deficit/Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Attention deficit- hyperactive patients;
Age between 6 and 14;
Both sex;
Exclusion criteria:
Other psycologic or neurologic comorbidities;
Predominantly inattentive;
Prematurity or dysmaturity;
History of smoking in mother during pregnancy;
Not intrested in participating;
Age
From 6 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, research director who will collect data and evaluate outcomes and pediatric psychologist, were blinded in this survey.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the research, Shahid sadoughi university of medical sciences
Disturbance of activity and attention Attention deficit: disorder with hyperactivity, hyperactivity disorder syndrome, with hyperactivity
Primary outcomes
1
Description
Connors parent rating scale
Timepoint
In the beginning of the study, after the first period of milk consumption, before the second period of milk consumtion, after the second period of milk consumption
Method of measurement
Connors Parent Questionnaire
2
Description
Conners teacher rating scale
Timepoint
In the beginning of the study, after the first period of milk consumption, before the second period of milk consumtion, after the second period of milk consumption
Method of measurement
Conners teacher questionnaire
Secondary outcomes
1
Description
Side effect
Timepoint
In the beginning of the study, after the first period of milk consumption, before the second period of milk consumtion, after the second period of milk consumption
Method of measurement
Questionnaire form
Intervention groups
1
Description
Intervention group: Intervention group in this double blind crossover randomized clinical trial on children with attention-deficit/hyperactivity disorder will be chosen from patients between 6 to 14 years old and both sex. Patients will experience both of mare milk and cow milk consumption during pharmacological treatment( Ritalin 1mg/kg) in two 45 days periods. In addition, they will have a 7 days wash out period between to main periods. Patients will drink 250 ml milk every day. Milk will be pasteurized at 63°C for 30 minutes. 32 patients were divided into 2 groups using a random number table: First group will consume mare milk for 45 days and after washout period( 7 days) use cow milk for 45 days.
Category
Treatment - Other
2
Description
Intervention group: Intervention group 2 ( second group) will consume cow milk for 45 days and after washout period( 7 days), use mare milk for 45 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Poly-Clinic Of Baghaei Pour
Full name of responsible person
Seyedeh Zahra Jokar Jandaghy
Street address
Department of Iranian Traditional Medicine, Faculty of Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
z.jokar@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
zohreh musavi
Street address
Department of Iranian Traditional Medicine, Faculty of Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3723 8915
Email
mosavi_yazddent@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
seyedeh zahra jokar jandaghy
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Department of Iranian Traditional Medicine, Faculty of Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3628 9681
Fax
+98 35 3629 6891
Email
z.jokar@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
seyedeh zahra jokar jandaghy
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Department of Iranian Traditional Medicine, Faculty of Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3628 9681
Fax
+98 35 3629 6891
Email
z.jokar@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
seyedeh zahra jokar jandaghy
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Department of Iranian Traditional Medicine, Faculty of Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3628 9681
Fax
+98 35 3629 6891
Email
z.jokar@ssu.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