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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012815
Receipt No. R000014950
Scientific Title Effects of supplementation for liver disease on compensated cirrhotic patients: a randomized, double-blind, placebo-controlled trial
Date of disclosure of the study information 2014/01/14
Last modified on 2015/01/12

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Basic information
Public title Effects of supplementation for liver disease on compensated cirrhotic patients: a randomized, double-blind, placebo-controlled trial
Acronym Effects of BCAA and zinc-enriched supplement on cirrhotic patients: a randomized, double-blind, placebo-controlled trial
Scientific Title Effects of supplementation for liver disease on compensated cirrhotic patients: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym Effects of BCAA and zinc-enriched supplement on cirrhotic patients: a randomized, double-blind, placebo-controlled trial
Region
Japan

Condition
Condition HCV-related liver disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effects of BCAA and zinc-enriched supplementation on prognostic factors in HCV-infected patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcomes were the following known prognostic factors for patients with chronic liver disease: 1) platelet count, 2) serum albumin level, 3) serum AFP level, 4) HOMA-IR value, 5) serum BTR, and 6) serum zinc level.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 In the supplement group, the patients were given two sachets of the BCAA and zinc-enriched supplement containing 6400 mg/day BCAA and 10 mg/day zinc (Aminofeel, Seikatsu Bunkasya Co. Inc, Chiba, Japan) once after breakfast and another at bedtime.
Interventions/Control_2 In the placebo group, the patients were administered a sachet of placebo after breakfast and another at bedtime. The BCAA, trace elements and vitamins were replaced with cornstarch in the placebo.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. > 65 years-old
2. HCV infection
3. Serum albumin level is more than 3.5 g/dL and less than 4.0 g/dL
4. Written informed consent
Key exclusion criteria 1. Subjects who had taken the supplement
2. Subjects who were treated with BCAA-containing agents
3. Subjects who were treated with antidiabetic agents
4. Subjects who were treated with zinc-containing agent or supplement
5. Subjects with obstruction of gut
6. Subjects with hepatic encepharlopathy
7. Subjects with severe hepato-renal diseases
8. Subjects with hepatocellular carcinoma
9. Subjects with risky esophageal varices
10. Subjects with other liver diseases including hepatitis B-related liver disease, alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, haemochromatosis, Wilson disease
11. HCV-infected subjects who are or will be treated with interferon thrapy
12. Subject with any type of severe extra-hepatic diseases
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Sata
Organization Kurume University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume-city, Fukuoka, Japan
TEL 0942-35-3311
Email msata@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takumi Kawaguchi
Organization Kurume University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume-city, Fukuoka, Japan
TEL 0942-35-3311
Homepage URL
Email takumi@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization Health and Labour Sciences Research Grants for Research on Hepatitis from the Ministry of Health, Labour and Welfare of Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1. Department of Gastroenterology and Rheumatology, Fukushima Medical University, Fukushima, Japan.
2. Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University, Chiba, Japan.
3. Department of Gastroenterology, Faculty of Medicine, Oita University, Yuhu, Japan.
4. Narao Medical Center, Shinkamigoto, Japan.
5. Department of Medical Oncology and Hematology, Sapporo Medical University, School of Medicine, Sapporo, Japan.
6. Biostatistics Center, Kurume University, Kurume, Japan.
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 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There was no significant difference in platelet count, albumin level, and HOMA-IR value between the supplement and control groups. In the supplement group, the BTR and zinc levels were significantly increased compared with the placebo group . No significant differences were observed in AFP levels between the groups in the whole analysis. However, a stratification analysis showed a significant reduction in delta AFP levels in the supplement group, with elevated AFP levels compared with the other groups.
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 Completed
Date of protocol fixation
2011 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 20 Day
Last follow-up date
2014 Year 08 Month 05 Day
Date of closure to data entry
2014 Year 08 Month 05 Day
Date trial data considered complete
2014 Year 08 Month 05 Day
Date analysis concluded
2014 Year 08 Month 05 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 10 Day
Last modified on
2015 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014950

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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