Evaluation of the effects of camel milk and chicory inulin on clinical problems and oxidative stress biomarkers in children with autism spectrum disorders
The purpose of this study is to investigate the effects of camel milk and chicory inulin on severity of autism symptoms and enzymatic and non-enzymatic antioxidant activities in autistic children
Design
A Randomised, superiority, parallel group trial without blinded outcome assessment. 99 autistic children will be randomized into intervention and control groups by using stratified random assignment method.
Settings and conduct
99 autistic children of Mashhad centers for autism will be randomly assigned into control and intervention groups by using the stata software.
At the baseline and the end of the study demographic questionnaire, Gilliam Autism Rating Scale (GARS) and Autism Treatment Evaluation Checklist (ATEC) will be completed by interviewing parents. A 5 mL blood sample will be taken from each subject before and after intervention for the measurement of blood antioxidant status and malondialdehyde (MDA) levels.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Autistic children Ages between 3-15 years old
Exclusion criteria: Allergy to camel milk or chicory Inulin; subjects with Chronic Infectious Diseases, organic diseases or other Psychiatric and neurological disorders; consuming camel milk or pre/probiotics’ products
Intervention groups
The intervention group 1 will receive camel milk and the intervention group 2 will receive chicory inulin powder for 7 weeks. The control group will not receive any intervention. The routine treatment will be continued in all the groups.
Main outcome variables
Changes in the serum levels of catalase, superoxide dismutase, total thiols and MDA and scores of GARS and ATEC before and after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181227042147N1
Registration date:2019-05-25, 1398/03/04
Registration timing:prospective
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Seyed Jamal Mirmoosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8930
Email address
mirmj931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-27, 1398/03/06
Expected recruitment end date
2019-06-01, 1398/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of camel milk and chicory inulin on clinical problems and oxidative stress biomarkers in children with autism spectrum disorders
Public title
The therapeutic effects of camel milk and chicory inulin in autistic children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children with DSM 5 diagnosis of autism
Ages between 3 and 15 years old
Exclusion criteria:
History of allergy to camel milk or chicory Inulin
Chronic Infectious Diseases or AIDS
Organic diseases
Other Psychiatric and neurological disorders (for example: epilepsy, seizure, syndromes, ...)
consuming camel milk
consuming pre/probiotics’ products
Age
From 3 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, stratified random assignment method is used.The random assignment sequence is determined using the stata software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah 18 St, Danshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2018-11-24, 1397/09/03
Ethics committee reference number
IR.MUMS.REC.1397.215
Health conditions studied
1
Description of health condition studied
Autism spectrum disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Autism disorder Severity
Timepoint
At baseline and after 7 weeks of intervention
Method of measurement
Gilliam Autism Rating Scale-GARS- Questionnaire
2
Description
Evaluating the efficacy of treatment
Timepoint
At baseline and after 7 weeks of intervention
Method of measurement
Autism Treatment Evaluation Checklist (ATEC)
Secondary outcomes
1
Description
Superoxide Dismutase (SOD) activity
Timepoint
At baseline and end of intervention (after 7 weeks)
Method of measurement
Spectrophotometry
2
Description
Total thiols concentration
Timepoint
At baseline and end of intervention (after 7 weeks)
Method of measurement
Spectrophotometry
3
Description
Catalase activity
Timepoint
At baseline and end of intervention (after 7 weeks)
Method of measurement
Spectrophotometry
4
Description
Malondialdehyde (MDA)
Timepoint
At baseline and end of intervention (after 7 weeks)
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Intervention group 1: will receive for 7 weeks both their routine treatment and 10 ml/kg body weight camel milk daily in 2 divided doses. To comply with sanitary ordinances, camel milk will be pasteurized in the Food Sciences and Technology Complex of Ferdowsi University of Mashhad.
Category
Treatment - Drugs
2
Description
Intervention group 2: will receive for 7 weeks their routine treatment plus 4 g of chicory inulin powder daily . The chicory inulin powder in this trial is manufactured by Farasoodmand-Razi Knowledge Enterprise.
Category
Treatment - Drugs
3
Description
Control group: will receive their routine treatment without any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad centers for autism
Full name of responsible person
Seyed Jamal Mirmoosavi
Street address
Faculty of Persian and Complementary Medicine, Pardis complex, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8930
Fax
+98 51 3882 9279
Email
mirmj931@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah 18 St, Danshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3882 3255
Fax
+98 51 3882 3251
Email
mirmj931@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Jamal Mirmoosavi
Position
PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian and Complementary Medicine, Pardis complex, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8930
Fax
+98 51 3882 9279
Email
mirmoosavij@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Yousefi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian and Complementary Medicine, Pardis complex, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8930
Fax
+98 51 3882 9279
Email
yousefim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Jamal Mirmoosavi
Position
PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian and Complementary Medicine, Pardis complex, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8930
Fax
+98 51 3882 9279
Email
mirmj931@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Observance of ethics
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