UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014142 |
|---|---|
| Receipt number | 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 10:02:31 |
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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
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
fujiirola@yahoo.co.jp
Sponsor or person
Institute
Osaka City Juso Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016465
