NCT02321579

Brief Summary

This study is designed as a hospital-based cross-sectional and randomized placebo-controlled intervention trial. One hundred and fifty patients with either cirrhosis or cirrhosis combined with hepatocellular carcinoma (HCC) who meet the inclusion criteria will be recruited from Taichung General Veterans Hospital. One hundred patients will be randomly assigned to either the 1) placebo group (n = 25); 2) vitamin B-6 group; (50 mg/d, n = 25); 3) glutathione (GSH) group (500 mg/d, n = 25); or 4) vitamin B-6 (50 mg/d) plus GSH (500 mg/d) group (n = 25) for 3 mo. Data on demography, anthropometry and medical history will be collected. Patients with cirrhosis or cirrhosis combined with HCC will have fasting blood drawn in the clinics. Additionally, patients who participated in the intervention study will have blood drawn at month 0, 1, 2 and 3 during intervention period. Hematological measurements, plasma vitamin B-6 status, GSH, inflammatory markers, homocysteine, cysteine, SAM, SAH, oxidative stress indicator, oxidized GSH and GSH related antioxidant enzyme activities will be analyzed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 22, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

December 9, 2014

Last Update Submit

December 19, 2014

Conditions

Liver CirrhosisLiver Cancer

Outcome Measures

Primary Outcomes (1)

  • Oxidative stress marker (MDA concentation)

    3 months

Secondary Outcomes (1)

  • Glutathione related enzyme activities

    3 months

Study Arms (4)

Negative control

PLACEBO COMPARATOR

Dextrins

Dietary Supplement: Dextrins

Supplement 1

EXPERIMENTAL

50 mg/d vitamin B-6

Dietary Supplement: vitamin B-6

Supplement 2

EXPERIMENTAL

500 mg/d Glutathione

Dietary Supplement: Glutathione

Supplement 3

EXPERIMENTAL

50 mg/d vitamin B-6 plus 500 mg/d Glutathione

Dietary Supplement: vitamin B-6Dietary Supplement: Glutathione

Interventions

vitamin B-6DIETARY_SUPPLEMENT

50 mg/d

Supplement 1Supplement 3
GlutathioneDIETARY_SUPPLEMENT

500 mg/d

Supplement 2Supplement 3
DextrinsDIETARY_SUPPLEMENT

50 mg/d

Negative control

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 20 to 80 years old
  • patients are diagnosed as cirrhosis or cirrhosis combined with hepatocellular carcimoma

You may not qualify if:

  • patients are currently taking any nutrient supplements
  • patients with cardiac, renal, gastrointestinal or diabetic diseases
  • patients are currently taking any medication which will interfere with vitamin B-6 or glutathione metabolism〔i.e., phenobarbital, phenytoin, cycloserine, pyrazinamide, isoniazid, (thio)semicarbazide, hydramitrazine, phenelzine, carbidopa, levodopa, hydralazine, steroids and penicillamine)
  • patients are in pregnant or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisLiver Neoplasms

Interventions

Vitamin B 6GlutathioneDextrins

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

PicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsStarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Shao-Bin Cheng, MD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chia Huang, PhD

CONTACT

+886-4-24730022ych@csmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 22, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

July 1, 2017

Last Updated

December 22, 2014

Record last verified: 2014-12

Locations

TW(1)