UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized-Controlled Trial of Vitamin D Supplementation in Children with Autism Spectrum Disorder
Title of the study (Brief title)	Vitamin D Supplementation in Children with Autism Spectrum Disorder
Region	Africa

Condition
Condition	ASD
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to assess the effects of vitamin D supplementation on the core symptoms of autism in children. ASD patients were randomized to receive vitamin D3 or placebo for 4 months. The serum levels of 25-hydroxycholecalciferol (25 (OH)D) were measured at the beginning and at the end of the study. The autism severity and social maturity of the children were assessed by the Childhood Autism Rating Scale (CARS), Aberrant Behavior Checklist (ABC), Social Responsiveness Scale (SRS), and the Autism Treatment Evaluation Checklist (ATEC)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the effect of vitamin D supplementation on the core symptoms of ASD in children
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vitamin D3 300 IU/kg maximum 5000 IU per day for 4 months
Interventions/Control_2	Placebo drops for 4 months
Interventions/Control_3
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	10 years-old >=
Gender	Male and Female
Key inclusion criteria	Child has a diagnosis of autistic disorder Child did not have developmental delays before the age of 12 months
Key exclusion criteria	Children with a history of other developmental disorders or psychiatric diseases were excluded. In addition, patients were excluded if they had a clinically significant chronic medical condition, including; anemia, brain malformations, metabolic diseases, seizures, and current use of pharmacotherapy (e.g., psychiatric medications) within the preceding 6 months. Also, patients with gastrointestinal disease associated with malabsorption were excluded. Finally, all patients were not started on any other therapies as vitamins or other alternative therapies for 2 weeks before and during the study period.
Target sample size	100

Research contact person
Name of lead principal investigator	Khaled Saad
Organization	Assiut university
Division name	pediatrics
Address	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL	+201006080182.
Email	khaled.ali@med.au.edu.eg

Public contact
Name of contact person	Khaled Saad
Organization	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name	pediatrics
Address	Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL	+20882368373
Homepage URL
Email	med@aun.edu.eg

Sponsor
Institute	No sponsor
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	2015-253
Org. issuing International ID_1	CONEM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2015 Year 08 Month 30 Day
Date of closure to data entry	2015 Year 11 Month 01 Day
Date trial data considered complete	2016 Year 01 Month 01 Day
Date analysis concluded	2016 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Supplementation of vitamin D was well tolerated by the ASD children. The daily doses used in the therapy group was 300 IU vitamin D3/kg/day, not to exceed 5,000 IU/day. The autism symptoms of the children improved significantly, following 4-month vitamin D3 supplementation, but not in the placebo group. This study demonstrates the efficacy and tolerability of high doses of vitamin D3 in children with ASD.
Other related information

Management information
Registered date	2015 Year 12 Month 19 Day
Last modified on	2017 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023414