UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020281 |
|---|---|
| Receipt number | 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 04:20:35 |
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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.
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
med@aun.edu.eg
Sponsor or person
Institute
No sponsor
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023414
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| Registered date | File name |
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| Registered date | File name |
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