UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020281
Receipt No. R000023414
Scientific Title Randomized-Controlled Trial of Vitamin D Supplementation in Children with Autism Spectrum Disorder
Date of disclosure of the study information 2015/12/31
Last modified on 2017/04/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized-Controlled Trial of Vitamin D Supplementation in Children with Autism Spectrum Disorder
Acronym Vitamin D Supplementation in Children with Autism Spectrum Disorder
Scientific Title Randomized-Controlled Trial of Vitamin D Supplementation in Children with Autism Spectrum Disorder
Scientific Title:Acronym 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
1st name
Middle name
Last name Khaled Saad
Organization Assiut university
Division name pediatrics
Zip code
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
1st name
Middle name
Last name Khaled Saad
Organization Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Division name pediatrics
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 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.
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 04 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.