UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial comparing zinc-BCAA combination therapy with BCAA monotherapy in liver cirrhosis patients with hypoalbuminemia
Acronym	Randomized controlled trial comparing zinc-BCAA combination therapy with BCAA monotherapy in liver cirrhosis patients with hypoalbuminemia
Scientific Title	Randomized controlled trial comparing zinc-BCAA combination therapy with BCAA monotherapy in liver cirrhosis patients with hypoalbuminemia
Scientific Title:Acronym	Randomized controlled trial comparing zinc-BCAA combination therapy with BCAA monotherapy in liver cirrhosis patients with hypoalbuminemia
Region	Japan

Condition
Condition	Liver cirrhosis with hypoalbuminemia
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the synergistic therapeutic effect of zinc and BCAA on hypoalbuminemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of serum albumin
Key secondary outcomes	1)Achievement rate of serum albumin>3.5g/dL, value of serum albumin 2)Changes of child pugh score, ALBI score 3)Changes of Skeletal muscle index(BIA), grip strength, SARC-F 4)Cumulative incidence rate of HCC 5)Cumulative incidence rate of acute decompensation and ACLF 6)Overall survival 7)Achievement rate of serum zinc>80mcg/dl value, changes of serum zinc 8)Changes of NH3, BTR 9)Changes of liver fibrosis marker(type4 collagen 7s, autotaxine and M2BPGi) and scoring system(FIB4 index, APRI)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Zinc + BCAA(12g/day). Starting dose of zinc is 50mg/day for <60kg, 75mg/day for 60kg-80kg, 100mg/day for >80kg. For cases with the serum zinc level is less than 80 mcg/dl at 4 and 8 weeks of administration, the amount of zinc is increased by 25mg/day. Total administration period is 12 weeks.
Interventions/Control_2	BCAA(12g/day). Total administration period is 12 weeks.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with hypozincemia and hypoalbuminemia due to liver cirrhosis, specifically patients who meet all the following conditions 1) Hypozincemia (<70mcg/dl) 2) hypoalbuminemia (<3.5g/dL)
Key exclusion criteria	1)Beyond Child-Pugh score 8. 2)Severe hypoalbuminemia (Serum albumin less than 2.8g/dL) 3)Past history of hepatic encephalopathy 4)Doubtful case of Wilson disease 5)Symptomatic hypozincemia 6)Severe renal dysfunction (serum creatinine more than 2.0 mg/dl) 7)Malabsorption due to digestive diseases 8)Poor oral intake due to alcohol use disorder and anorexia nervosa 9)Severe dementia
Target sample size	64

Research contact person
Name of lead principal investigator	1st name Nobuhiro Middle name Last name Nkamoato
Organization	Keio University, School of Medicine
Division name	Division of Gastroenterology and Hepatology
Zip code	1608582
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	+81-3-3353-1211
Email	nobuhiro@z2.keio.jp

Public contact
Name of contact person	1st name Ryosuke Middle name Last name Kasuga
Organization	Keio University, School of Medicine
Division name	Division of Gastroenterology and Hepatology
Zip code	1608582
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	+81-3-3353-1211
Homepage URL
Email	rk-keio2020@keio.jp

Sponsor
Institute	Keio University, School of Medicine
Institute
Department

Funding Source
Organization	Keio University, School of Medicine
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	Keio University, School of Medicine
Address	35 Shinanomachi Shinjuku-ku, Tokyo
Tel	+81-3-3353-1211
Email	med-rinri-jimu@adst.keio.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	2022 Year 07 Month 11 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	Preinitiation
Date of protocol fixation	2022 Year 06 Month 14 Day
Date of IRB	2022 Year 06 Month 14 Day
Anticipated trial start date	2022 Year 07 Month 11 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 08 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055072