UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ketogenic diet versus gluten free casein free diet in autistic children: a case-control study
Title of the study (Brief title)	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	EL Rashidy O
Organization	Ain Shams university
Division name	Pediatrics
Address	Faculty of Medicine, Ain Shams university, Egypt
TEL	+201223148425
Email	doctor_juice@hotmail.com

Public contact
Name of contact person	Khaled Saad
Organization	Assiut University, Assiut, Egypt
Division name	pediatrics
Address	Assiut University, Assiut, Egypt
TEL	+20882413683
Homepage URL
Email	khaled.ali@med.au.edu.eg

Sponsor
Institute	Assiut university
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 12 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024722