臨床研究等提出・公開システム

Scientific Title	Ascorbic acid treatment for childhood Charcot-Marie-Tooth disease 1A (Ascorbic acid for CMT1A)
Public Title	Ascorbic acid treatment for childhood Charcot-Marie-Tooth disease 1A (Ascorbic acid treatment for childhood CMT 1A)

Contact for Scientific Queries	Name	SHIOHAMA TADASHI
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, JAPAN
	Telephone	+81-43-226-2144
	E-mail	asuha_hare@chiba-u.jp
Contact for Public Queries	Name	SHIOHAMA TADASHI
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, JAPAN
	Telephone	+81-43-226-2144
	E-mail	asuha_hare@chiba-u.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Oct. 03, 2019
Actual date of first enrollment		Oct. 25, 2019
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Children under 18 years of age with confirmed PMP22 duplication in genetic testing. 2. Normal data in blood examination. 3. Normal data in urinary analysis. 4. Written informed consent from the patient, or parents in case of children.
	Exclusion Criteria	1. The patient has already taken daily vitamin treatment. 2. When the investigator or the investigator considers it inappropriate to conduct this study safely.
	Age Minimum	No limit
	Age Maximum	18age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Charcot-Marie-Tooth disease type 1A
Intervention(s)		ascorbic acid dayly intake
Health Condition(s) Keyword		CMT1A
Intervention(s) Keyword		ascorbic acid
Health Condition(s) Code		G600
Intervention(s) Code
Primary Outcome(s)		CMT score
Secondary Outcome(s)		Electrophysiological examination, Six minutes walking distance

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan, Chiba
Telephone	+81-43-226-7171
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	Sept. 02, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history