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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014142
Receipt No. R000016465
Scientific Title Effects of Phlebotomy for the Japanese patients with NAFLD
Date of disclosure of the study information 2014/06/04
Last modified on 2016/06/02

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Basic information
Public title Effects of Phlebotomy for the Japanese patients with NAFLD
Acronym Effects of Phlebotomy for the patients with NAFLD
Scientific Title Effects of Phlebotomy for the Japanese patients with NAFLD
Scientific Title:Acronym Effects of Phlebotomy for the patients with NAFLD
Region
Japan

Condition
Condition NAFLD
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of phlebotomy on liver function for the patients with NAFLD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ALT
Key secondary outcomes CBC
biochemical test (gamma-GTP, LDL-C, HDL-C, TG, FBS, UA, IRI, HOMA-IR, Fe, Ferritin)
Body fat measurement by CT
Body measurement
Body composition analysis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 phlebotomy associated with dietary and lifestyle counseling
removal of 400 mL(man) or 300 mL(woman) of blood at each biweekly or monthly
session, depending on patient tolerance and availability, until near-iron depletion (NID) was reached.
Interventions/Control_2 dietary and lifestyle counseling
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Non drinker (<20 g/day)
2. The patients who was excluded other chronic liver disease were excluded
3. The patients who diagnosed as fatty liver by abdominal CT or ultrasonography
Key exclusion criteria 1. Serum ferritin < 20 ng/ml or Hb < 11 g/dl
2. Patients who had any other liver disease (such as acute hepatitis, exacerbation of chronic hepatitis), cirrhosis (Child B or C), or hepatocellular carcinoma.
3. Pregnant women or women who suspected of being pregnant.
4. Patients who attending physician judged as being inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Fujii
Organization Osaka City Juso Hospital
Division name Department of Gastroenterology
Zip code
Address 2-12-27, nonakakita, yodogawa-ku, Osaka
TEL 06-6150-8000
Email fujiirola@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Fujii
Organization Osaka City Juso Hospital
Division name Department of Gastroenterology
Zip code
Address 2-12-27, nonakakita, yodogawa-ku, Osaka
TEL 06-6150-8000
Homepage URL
Email fujiirola@yahoo.co.jp

Sponsor
Institute Osaka City Juso Hospital
Institute
Department

Funding Source
Organization Osaka City Juso Hospital
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
2014 Year 06 Month 04 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 05 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 02 Day
Last modified on
2016 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016465

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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