UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012815 |
|---|---|
| Receipt number | 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 14:00:45 |
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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
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
takumi@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014950
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