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 |
Randomized-Controlled Trial of Vitamin D Supplementation in Children with Autism Spectrum Disorder
Vitamin D Supplementation in Children with Autism Spectrum Disorder
Randomized-Controlled Trial of Vitamin D Supplementation in Children with Autism Spectrum Disorder
Vitamin D Supplementation in Children with Autism Spectrum Disorder
Africa |
ASD
Pediatrics |
Others
NO
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)
Efficacy
To evaluate the effect of vitamin D supplementation on the core symptoms of ASD in children
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
Vitamin D3 300 IU/kg maximum 5000 IU per day for 4 months
Placebo drops for 4 months
3 | years-old | <= |
10 | years-old | >= |
Male and Female
Child has a diagnosis of autistic disorder
Child did not have developmental delays before the age of 12 months
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.
100
1st name | |
Middle name | |
Last name | Khaled Saad |
Assiut university
pediatrics
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
+201006080182.
khaled.ali@med.au.edu.eg
1st name | |
Middle name | |
Last name | Khaled Saad |
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
pediatrics
Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
+20882368373
med@aun.edu.eg
No sponsor
self funding
Self funding
YES
2015-253
CONEM
2015 | Year | 12 | Month | 31 | Day |
Published
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.
Main results already published
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 05 | Month | 01 | Day |
2015 | Year | 08 | Month | 30 | Day |
2015 | Year | 11 | Month | 01 | Day |
2016 | Year | 01 | Month | 01 | Day |
2016 | Year | 02 | Month | 01 | Day |
2015 | Year | 12 | Month | 19 | Day |
2017 | Year | 04 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023414