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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name