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Effects of vitamin D and/or aquatic exercise on IL-1β and IL-1RA serum levels and behavior of children with autism spectrum disorder

Protocol summary

Study aim
Evaluation of the effect of vitamin D and / or Aquatic exercise on serum levels of IL-1B, IL-1RA and the behavior of children with autism spectrum disorder
Design
A randomized controlled trial with parallel, double-blind, randomized groups of 80 children with autism spectrum disorder. Excel software rand function was used for randomization.
Settings and conduct
Execution of Blood sampling at Razi lab aquatic Exercise in the Behzisty pool of Rasht Vitamin D supplements based on the prescription of pediatric neurosurgeons Participants, Blood sampling, Laboratory scientist and Expert statistician, except the researcher and his aides, did not know the grouping of people in the research groups
Participants/Inclusion and exclusion criteria
Inclusion criteria included psychiatrist –diagnosed ASD (by Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V)), male gender, aged 6-8 years, no change in any medical, dietary or behavior treatment during the study, and parental informed consent.
Intervention groups
Aquatic Exercise group, vitamin D supplementation group, combination of Training and supplementation group and control group
Main outcome variables
Improving IL-1b, IL-1ra, vitamin D serum levels, stereotypic behavior

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180503039517N5
Registration date: 2020-09-26, 1399/07/05
Registration timing: retrospective

Last update: 2020-09-26, 1399/07/05
Update count: 0
Registration date
2020-09-26, 1399/07/05
Registrant information
Name
Soleyman Ansari Kolachahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2906
Email address
solomonansari@phd.iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-18, 1399/05/28
Expected recruitment end date
2020-08-24, 1399/06/03
Actual recruitment start date
2020-08-18, 1399/05/28
Actual recruitment end date
2020-08-25, 1399/06/04
Trial completion date
2020-10-30, 1399/08/09
Scientific title
Effects of vitamin D and/or aquatic exercise on IL-1β and IL-1RA serum levels and behavior of children with autism spectrum disorder
Public title
Effects of vitamin D and/or aquatic exercise on IL-1β and IL-1RA serum levels and behavior of children with autism spectrum disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
psychiatrist –diagnosed ASD (by Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V)) Male gender aged 6-8 years no change in any medical, dietary or behavior treatment during the study parental informed consent
Exclusion criteria:
Having comorbid disability or other Neuro-cognitive disorders receiving vitamin D supplements in the last 6 months
Age
From 6 years old to 8 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Eighty children aged 6-8 years with autism spectrum disorder are selected by the available sampling method. Each person is assigned a number. It is then used to create groups randomly using the RAND function in Excel software. Eventually, 20 people will be replaced in each group (three experimental groups and one control group).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blood samples and laboratory analysis experts are also unaware of the type of intervention and participating groups. Statistical analysts are not aware of the individuals and how the research is conducted.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rasht Azad University Medical Sciences
Street address
Azad University of Rasht, Lakan Ave
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2020-08-17, 1399/05/27
Ethics committee reference number
IR.IAU.RASHT.REC.1399.035

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
IL-1B serum levels
Timepoint
One week before starting and one week after terminating of intervention
Method of measurement
Diaclone human kit for IL-1B

2

Description
IL-1ra serum levels
Timepoint
One week before starting and one week after terminating of intervention
Method of measurement
ZellBio human kit for IL-1RA

3

Description
vitamin D serum level
Timepoint
One week before starting and one week after terminating of intervention
Method of measurement
Pars Azmoon human kit

4

Description
stereotypic behavior
Timepoint
One week before starting and one week after terminating of intervention
Method of measurement
Gars-2, stereotypic behaviors subscale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: aquatic exercise (10 weeks, 2 session per week, 60 min training in pool). ٍEach session includes a 5-minute warm-up, 15-minute orientation training, 20-minute basic swimming skills, 15-minute free swim and a 5-minute cool down.
Category
Lifestyle

2

Description
Intervention group: vitamin D supplementation (for 10 weeks, once a week orally, along with having dinner, 500000 IU vitamin D). Vitamin D3 will be provided by Dana Pharmaceutical Company.
Category
Lifestyle

3

Description
Intervention group: Combination of aquatic exercise and vitamin D supplementation. In this group, participants will receive both the intervention of the first group (aquatic exercise for 10 weeks) and the second group (vitamin D supplementation for 10 weeks) according to the same process mentioned above.
Category
Lifestyle

4

Description
Control group: Participants in this group are asked to continue their normal and routine programs during the research period, as before. But refrain from participating in new diet, medicine and physical activity programs.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan Autism Mehr Rain Association
Full name of responsible person
Mehdi Zahedi Kalashtari
Street address
second Fooladloo, Saffari Ave, Bisoton Ave
City
Rasht
Province
Guilan
Postal code
4193191933
Phone
+98 13 3351 3235
Email
Solomonansari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Seydavi
Street address
Azad University of Rasht, Lakan Ave
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3342 4073
Email
solomonansari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Fahimeh AdibSaber
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ansar Sport Club, 6th Ave, Keshavarz Ave, Valiasr Ave
City
Rasht
Province
Guilan
Postal code
4139617379
Phone
+98 13 3375 2906
Email
adibsaber@iaurasht.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahimeh AdibSaber
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ansar Sport Club, 6th Ave, Keshavarz Ave, Valiasr Ave
City
Rasht
Province
Guilan
Postal code
4139617379
Phone
+98 13 3375 2906
Email
adibsaber@iaurasht.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fahimeh Adibsaber
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ansar Sport Club, 6th Ave, Keshavarz Ave, Valiasr Ave
City
Rasht
Province
Guilan
Postal code
4139617379
Phone
+98 13 3375 2906
Email
adibsaber@iaurasht.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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
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