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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026567
Receipt No. R000030505
Scientific Title An efficacy of oral BCAA and vitamin D to Sarcopenia and bone metabolism in cirrhosis patients with hypoalbuminaemia
Date of disclosure of the study information 2017/03/16
Last modified on 2020/04/29

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Basic information
Public title An efficacy of oral BCAA and vitamin D to Sarcopenia and bone metabolism in cirrhosis patients with hypoalbuminaemia
Acronym Efficacy of oral BCAA and Vitamin D to a cirrhosis patients
Scientific Title An efficacy of oral BCAA and vitamin D to Sarcopenia and bone metabolism in cirrhosis patients with hypoalbuminaemia
Scientific Title:Acronym Efficacy of oral BCAA and Vitamin D to a cirrhosis patients
Region
Japan

Condition
Condition cirrhosis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 efficacy of oral BCAA and vitamin D
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skeletal muscle mass, grip, bone density
Key secondary outcomes Subjective symptoms/objective symptom
Performance status
Mental symptom
Side effect

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Comparative randomized trial between 2 groups:only BCAA
Interventions/Control_2 Comparative randomized trial between 2 groups:BCAA+Vitamin D
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
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Decompensated cirrhosis with hypoalbuminemia
Key exclusion criteria Patient with inborn branch chain amino acid metabolic derangement
Hepatic encephalopathy more than 3
Total bilirubin value >3 mg/dl
patien with decrease of the protein composition ability in the liver
The patient allergic to milk
The patient who has the medical history of the hyperesthesia to BCAA medicine
The patient who is nursing and pregnant
Patient with uncotrolled HCC or other malignant tumor
Uncontrolled heart failure patient
Uncontrolled hypertension or diabetes
Patient with Chronic renal failure
Patient of hypercalcemia
Patient with hyperthyroidism
Patient who already takes other vitamin D Patien who takes the drug that combination with the vitamin D preparation is contraindicated
Patient with acute liver failure
Patient who were judged unsuitable by test responsibility doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Atsukawa
Middle name
Last name Masanori
Organization nippon medical chiba hokusoh hospital
Division name Gastroenterology
Zip code 2701613
Address 1715 Kamagari Inzai Chiba
TEL 0476991111
Email atsukawa-nms@umin.ac.jp

Public contact
Name of contact person
1st name Tomomi
Middle name
Last name Okubo
Organization Nippon Medical Chiba Hokusoh Hospital
Division name Gastroenterology
Zip code 2701613
Address 1715 Kamagari Inzai Chiba
TEL 0476991111
Homepage URL
Email atsukawa-nms@umin.ac.jp

Sponsor
Institute nippon medical chiba hokusoh hospital
Institute
Department

Funding Source
Organization nippon medical chiba hokusoh hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nipon medical Chiba hokuso Hospital
Address 1715 Kamagari Inzai Chiba
Tel 0476991111
Email araraki@nms.ac.jp

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
2017 Year 03 Month 16 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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
2017 Year 02 Month 28 Day
Anticipated trial start date
2017 Year 03 Month 16 Day
Last follow-up date
2023 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 15 Day
Last modified on
2020 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030505

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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