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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016770
Receipt No. 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

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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
Email 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/
Email bjorklund@conem.org

Sponsor
Institute Council for Nutritional and Environmental Medicine (CONEM).
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016846

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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