UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Phlebotomy for the Japanese patients with NAFLD
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hideki Fujii
Organization	Osaka City Juso Hospital
Division name	Department of Gastroenterology
Address	2-12-27, nonakakita, yodogawa-ku, Osaka
TEL	06-6150-8000
Email	fujiirola@yahoo.co.jp

Public contact
Name of contact person	Hideki Fujii
Organization	Osaka City Juso Hospital
Division name	Department of Gastroenterology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016465