Protocol summary
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Study aim
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Investigating the effect of L-Carnitine for the treatment of autism
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Design
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Randomized double blind and placebo-controlled clinical trial
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Settings and conduct
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The study will be conducted among children with autistic disorder attending Roozbeh Hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder - Children between the ages of 5 and 11 years - Having a minimum score of 12 in irritability. Exclusion criteria: Presence of any psychiatric disorder - History of allergy to medications used in this research - Presence of any active medical problem such as heart disease - History of uncontrolled seizure - Receiving any psychotropic medications except risperidone during past two weeks prior to the trial
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Intervention groups
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Intervention group: Patients treated with risperidone 1-3mg per day and L-Carnitine 50mg/kg per day. Control group: Patients treated with risperidone 1-3mg per day and placebo.
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Main outcome variables
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Severity of autism
General information
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Reason for update
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There was a typo regarding the dose of L-Canitine that I corrected it
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090117001556N136
Registration date:
2021-05-03, 1400/02/13
Registration timing:
prospective
Last update:
2023-01-06, 1401/10/16
Update count:
1
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Registration date
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2021-05-03, 1400/02/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-22, 1400/03/01
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Expected recruitment end date
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2023-05-22, 1402/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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L-Carnitine as an adjuvant therapy in the treatment of autism in children: randomized double blind and placebo controlled clinical trial
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Public title
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L-Carnitine for the treatment of autism
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
DSM-5 clinical diagnosis of autistic disorder
Children between the ages of 5 and 11 years
Having a minimum score of 12 in irritability
Exclusion criteria:
Presence of any psychiatric disorder
History of allergy to medications used in this research
Presence of any active medical problem such as heart disease
History of uncontrolled seizure
Receiving any psychotropic medications except risperidone during past two weeks prior to the trial
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Age
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From 5 years old to 11 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups)
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-30, 1399/09/10
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Ethics committee reference number
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IR.TUMS.DDRI.REC.1399.051
Health conditions studied
1
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Description of health condition studied
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Autistic disorder
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ICD-10 code
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F84.0
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ICD-10 code description
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Autistic disorder
Primary outcomes
1
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Description
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Severity of autism
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Timepoint
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Baseline and weeks 5, and 10
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Method of measurement
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By Aberrant Behavior Checklist-Community (ABC-C) and Childhood autism rating scale (CARS)
Intervention groups
1
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Description
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Intervention group: Patients treated with risperidone 1-3mg per day and L-Carnitine 150mg/kg per day.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients treated with risperidone 1-3mg per day and placebo.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The data will be distributed through final report
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When the data will become available and for how long
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5 years from 2022 to 2027
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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Users should cite the resource of data
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From where data/document is obtainable
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Prof Shahin Akhondzadeh
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What processes are involved for a request to access data/document
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by E mail
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Comments
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