UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021433 |
|---|---|
| Receipt number | R000024722 |
| Scientific Title | Ketogenic diet versus gluten free casein free diet in autistic children: a case-control study |
| Date of disclosure of the study information | 2016/03/12 |
| Last modified on | 2018/03/13 17:05:51 |
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Basic information
Public title
Ketogenic diet versus gluten free casein free diet in autistic children: a case-control study
Acronym
Ketogenic diet versus Gluten free Casein free diet in ASD
Scientific Title
Ketogenic diet versus gluten free casein free diet in autistic children: a case-control study
Scientific Title:Acronym
Ketogenic diet versus Gluten free Casein free diet in ASD
Region
| Africa |
Condition
Condition
autism spectrum disorder
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Ketogenic diet versus Gluten free Casein free diet on the core
symptoms of ASD children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All patients were assessed in terms of neurological examination, anthropometric measures, as well as Childhood Autism Rating Scale, Autism Treatment Evaluation Test questionnaire before and 6 months after starting diet.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Forty-five pre-pubertal children aged 3-8 years diagnosed with autism based on DSM-5 were enrolled in this study. Patients were equally divided into 3 groups, first group received ketogenic diet as modified Atkins diet,
Interventions/Control_2
The second group received gluten free casein free (GFCF) diet
Interventions/Control_3
The third group received balanced nutrition and served as control group.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 8 | years-old | > |
Gender
Male and Female
Key inclusion criteria
children with ASD
Key exclusion criteria
Children with known endocrine, cardiovascular, pulmonary, liver, kidney disease, or current fever.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | EL Rashidy O |
Organization
Ain Shams university
Division name
Pediatrics
Zip code
Address
Faculty of Medicine, Ain Shams university, Egypt
TEL
+201223148425
doctor_juice@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Khaled Saad |
Organization
Assiut University, Assiut, Egypt
Division name
pediatrics
Zip code
Address
Assiut University, Assiut, Egypt
TEL
+20882413683
Homepage URL
khaled.ali@med.au.edu.eg
Sponsor or person
Institute
Assiut university
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Ain Shams university, Egypt
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Egyptian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Whole study population included 45 patients with autism, 33 males (73.3%) and 12 females (26.7%). Their mean age was (5.29yrs). Ketogenic diet group(group I) showed significant improvement in CARS score (p0.000) while ATEC score showed significant improvement in speech ,social and cognition parameters with no change in behavior . Both diet groups showed marked improvement in ATEC and CARS score in comparison to control group yet ketogenic scored better results in cognition and sociability compared to GFCF diet group.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 05 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 11 | Day |
Last modified on
| 2018 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024722
