UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012891 |
|---|---|
| Receipt number | R000015063 |
| Scientific Title | Action investigation of carnitine in patients with anorexia nervosa |
| Date of disclosure of the study information | 2014/01/20 |
| Last modified on | 2018/01/21 14:33:20 |
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Basic information
Public title
Action investigation of carnitine in patients with anorexia nervosa
Acronym
CAN
Scientific Title
Action investigation of carnitine in patients with anorexia nervosa
Scientific Title:Acronym
CAN
Region
| Japan |
Condition
Condition
Anorexia Nervosa
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
*To test blood carnitine levels in patients with anorexia nervosa
*To assess the correlation of carnitine and the psychiatric manifestation in patients with anorexia nervosa
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
The body weight, blood carnitine levels, Symptom Rating Scale for Eating Disorders, General Health Questionnaire, Beck`s Depression Inventory-Second Ed, State-Trait Anxiety Inventory, Child Behavior Checklist, Global Assessment of Functioning, NIMH Global Obsessive-Compulsive Scale at start of therapy and finish of therapy, BMI exceeds 16.
Key secondary outcomes
Nutritional Status; ALB, Pre ALB, RBP
Liver Function; AST, ALT, gamma GTP
Renal Funciton; Creatinine, BUN
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 13 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with anorexia nervosa admitted to the department of psychiatry of Shiga University of Medical Science Hospital
Key exclusion criteria
*Arbitrary Hospitalization
When the patient or the protector does not agree to study
*Involuntary Hospitalization
When the protector does not agree to study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiko Inagaki |
Organization
Shiga University of Medical Science
Division name
Department of Community Psychiatric Medicine
Zip code
Address
Seta Tsukinowa-cho, Otsu City, Shiga, JAPNA
TEL
077-548-2291
kerosuke@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiko Inagaki |
Organization
Shiga University of Medical Science
Division name
Department of Community Psychiatric Medicine
Zip code
Address
Seta Tsukinowa-cho, Otsu City, Shiga, JAPNA
TEL
077-548-2291
Homepage URL
kerosuke@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Community Psychiatric Medicine of Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We assess the weight, blood carnitine levels, nutritional status, liver function, renal function, psychiatric manifestation at start of treatment and finish of treatment,BMI >= 16.
Management information
Registered date
| 2014 | Year | 01 | Month | 17 | Day |
Last modified on
| 2018 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015063
