UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016770 |
|---|---|
| Receipt number | R000016846 |
| Scientific Title | Vitamin D Status in Autism Spectrum Disorder and the Efficacy of Vitamin D Supplementation in Autistic Children |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2016/03/11 20:24:47 |
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Basic information
Public title
Vitamin D Status in Autism Spectrum Disorder and the Efficacy of Vitamin D Supplementation in Autistic Children
Acronym
Vitamin D and Autism
Scientific Title
Vitamin D Status in Autism Spectrum Disorder and the Efficacy of Vitamin D Supplementation in Autistic Children
Scientific Title:Acronym
Vitamin D and Autism
Region
| Africa |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Vitamin-D deficiency was previously reported in autistic children . However, the data on the relationship between vitamin D deficiency and the severity of autism is limited; also, the previous studies had several drawbacks such as absence of controls, small sample sizes and some were not conducted on children . We attempted to remedy some of these deficits in the present study by using a case-controlled cross sectional analysis conducted on a large patient group of ASD children to assess their vitamin D status compared to controls and the relationship between vitamin D deficiency and the severity of autism. We also conducted an open trial of vitamin D supplementation in ASD children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
We performed a case-controlled cross sectional analysis conducted on a 122 ASD children, to assess their vitamin D status compared to controls and the relationship between vitamin D deficiency and the severity of autism. We also conducted an open trial of vitamin D supplementation in ASD children. Fifty-seven % of the patients in the present study had vitamin D deficiency, and thirty % had vitamin D insufficiency. The mean 25-OHD levels in patients with severe autism were significantly lower than those in patients with mild/moderate autism. Serum 25-OHD levels had significant negative correlations with CARS scores.
Key secondary outcomes
Of the ASD group, 106 patients with low serum 25-OHD levels (<30 ng/ml) participated in the open label trial. They received 5000 IU/day of vitamin D3 for three months. Eighty-three subjects completed three months of daily vitamin D treatment. Collectively 80.72% (67/83) of subjects who received vitamin D3 treatment had significantly improved outcome, which was mainly in the sections of the CARS that measure behavior, eye contact and attention span.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vitamin D3 (300 IU/Kg/day not to
exceed 5,000 IU/day
Interventions/Control_2
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
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The present study included 122 Egyptian children with ASD (aged from three to nine years) participated in this case control, cross-sectional study. All patients were recruited from the neuropediatric clinics Assiut university hospitals and 5 private centers for autism in Assiut city, Upper Egypt.
Key exclusion criteria
children with feeding problems or malnutrition were excluded from the study. Subjects who had associated gastrointestinal problems, autoimmune disorders, anemia, neurological diseases (such as cerebral palsy and tuberous sclerosis) and metabolic disorders (e.g. phenylketonuria) as well as any subjects receiving vitamin D containing preparations and drugs that may affect vitamin D (e.g. steroid and antiepileptics) were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Khaled Saad |
Organization
Faculty of Medicine - Pediatric Department
Assiut University
Division name
Pediatric Department
Zip code
Address
Egypt, Assiut city, AL Noor Street, Almahata Avenue, Haj Ali Building, First Floor, Flat No. 1.
TEL
+2088-2389300
khaled.ali@med.au.edu.eg
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Geir Bjorklund, |
Organization
Council for Nutritional and Environmental Medicine (CONEM)
Division name
nutrition
Zip code
Address
Mo i Rana, Norway
TEL
4795255484
Homepage URL
http://www.conem.org/people/bjorklundbio/
bjorklund@conem.org
Sponsor or person
Institute
Council for Nutritional and Environmental Medicine (CONEM).
Institute
Department
Personal name
Funding Source
Organization
No funding was secured for this study.
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
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
| 2015 | Year | 04 | Month | 01 | 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
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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 11 | Day |
Last modified on
| 2016 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016846
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
