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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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14 May 2018 |
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Main ID: |
ChiCTR1800016113 |
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Date of registration:
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2018-05-12 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prospective Study of Vitamin A and Vitamin D Treatment in Children with Autism Spectrum Disorders
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Scientific title:
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Prospective Study of Vitamin A and Vitamin D Treatment in Children with Autism Spectrum Disorders |
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Date of first enrolment:
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2018-07-01 |
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Target sample size:
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vitamin A deficiency:70;vitamin D deficiency:70;both vitamin A and vitamin D deficieny:60; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=27374 |
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Study type:
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Relative factors research |
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Study design:
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Before-After control
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Dai Ying
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Address:
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136 Second Zhongshan Road, Yuzhong District, Chongqing, China
400014
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Telephone:
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+86 15823232665 |
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Email:
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1959712804@qq.com |
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Affiliation:
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Children's Hospital of Chongqing Medical University |
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Name:
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Dai Ying
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Address:
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136 Second Zhongshan Road, Yuzhong District, Chongqing, China
400014
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Telephone:
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+86 15823232665 |
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Email:
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1959712804@qq.com |
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Affiliation:
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Children's Hospital of Chongqing Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) Aged 1.5-18 years old, ASD patients identified by DSM-V, ADOS, SRS and ABC;
(2) There were no positive signs of nervous system examination and no obvious psychomotor retardation;
(3) No significant abnormalities were observed in EEG or MRI;
(4) Vitamin A and vitamin D were not added within 2 months before entering the group.
Exclusion criteria: History of other serious mental disorders, neurological diseases, chromosomal disease, inherited metabolic diseases, and other serious disease, such as audiovisual disorders, epilepsy, phenylketonuria, nodular brain sclerosis, neurofibroma, severe brain trauma, Autoimmune diseases, endocrine disease, cardiovascular, pulmonary disease, liver and kidney diseases. Guardians are reluctant to participate in researche.
Age minimum:
1.5
Age maximum:
18
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Autism Spectrum Disorders
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Intervention(s)
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vitamin A deficiency:vitamin A supplementation;vitamin D deficiency:vitamin D supplementation;both vitamin A and vitamin D deficieny:vitamin A and vitamin D supplementation;
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Primary Outcome(s)
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serum concentrations of vitamin A and vitamin D;Assessment of core symptoms of ASD;
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Secondary Outcome(s)
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sleeping problems;gastrointestinal tract problems;eating behavior;quality of life;
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Source(s) of Monetary Support
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Subject leader reserve fund of Children's Hospital of Chongqing Medical University
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Ethics review
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Status: Approved
Approval date: 26/04/2018
Contact:
Lu Zhongyi
+86 023 63664659
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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