## Protocol Section
### Identification Module
**NCT ID:** NCT02321579

**Brief Title:** Vitamin B-6 and Glutathione on Inflammation, Homocysteine, Oxidative Stress and Antioxidant Capacities

**Official Title:** The Effects of Vitamin B-6 and Glutathione on Inflammatory Responses, Homocysteine Metabolism, Oxidative Stress and Antioxidant Capacities in Patients With Liver Cirrhosis or Hepatocellular Carcinoma

#### Organization Study ID Info
**ID:** SF14261B
#### Organization
**Class:** OTHER
**Full Name:** Taichung Veterans General Hospital
### Status Module
#### Completion Date
**Date:** 2017-07

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2014-12-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-12-19

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2016-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-12

**Status Verified Date:** 2014-12

#### Study First Post Date
**Date:** 2014-12-22
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-09
**Study First Submit QC Date:** 2014-12-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Taichung Veterans General Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Liver cirrhosis is now the ninth leading cause of death and hepatocellular carcinoma (HCC) is the second leading cause of cancer mortality among men and women in Taiwan. Vitamin B-6 and glutathione (GSH) are metabolized in liver, the role of vitamin B-6 and GSH playing in the inflammatory responses and antioxidant function would be impaired during hepatic injury. The purpose of this study is going to assess the effects of individual or combined supplementation of vitamin B-6 and GSH on homocysteine, cysteine, the ratio of S-adenosylmethionine (SAM)/S-adenosylhomocysteine (SAH), oxidative stress, oxidized glutathione (GSSG) and GSH related antioxidant enzyme activities in patients with cirrhosis and cirrhosis combined with HCC.

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 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) 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, plasma vitamin B-6 status, GSH, inflammatory markers, homocysteine, cysteine, SAM, SAH, oxidative stress indicator, GSSG and GSH related antioxidant enzyme activities will be measured.

Hopefully, the results of this study could provide more pictures on the beneficial effects of vitamin B-6 and GSH supplementation on inflammatory responses, homocysteine, cysteine, the ratio of SAM/SAH, oxidative stress, GSSG and GSH related antioxidant enzyme activities in patients with cirrhosis and HCC.

### Conditions Module

**Conditions:**

- Liver Cirrhosis

- Liver Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Dextrins

**Intervention Names:**

- Dietary Supplement: Dextrins

**Label:** Negative control

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** 50 mg/d vitamin B-6

**Intervention Names:**

- Dietary Supplement: vitamin B-6

**Label:** Supplement 1

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 500 mg/d Glutathione

**Intervention Names:**

- Dietary Supplement: Glutathione

**Label:** Supplement 2

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** 50 mg/d vitamin B-6 plus 500 mg/d Glutathione

**Intervention Names:**

- Dietary Supplement: vitamin B-6

- Dietary Supplement: Glutathione

**Label:** Supplement 3

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Supplement 1

- Supplement 3

**Description:** 50 mg/d

**Name:** vitamin B-6

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Supplement 2

- Supplement 3

**Description:** 500 mg/d

**Name:** Glutathione

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- Negative control

**Description:** 50 mg/d

**Name:** Dextrins

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Measure:** Oxidative stress marker (MDA concentation)

**Time Frame:** 3 months

#### Secondary Outcomes

**Measure:** Glutathione related enzyme activities

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

1. patients are currently taking any nutrient supplements
2. patients with cardiac, renal, gastrointestinal or diabetic diseases
3. 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)
4. patients are in pregnant or lactation.

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ych@csmu.edu.tw

**Name:** Yi-Chia Huang, PhD

**Phone:** +886-4-24730022

**Phone Ext:** 12198

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Taichung

**Contacts:**

***Contact 1:***

- **Email:** ych@csmu.edu.tw

- **Name:** Yi-Chia Huang, PhD

- **Phone:** +886-4-24730022

- **Phone Ext:** 12198

- **Role:** CONTACT

***Contact 2:***

- **Name:** Shao-Bin Cheng, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Taiwan

**Facility:** Taichung Veterans General Hospital

**Status:** RECRUITING

**Zip:** 40705

#### Overall Officials

**Official 1:**

**Affiliation:** Taichung Veterans General Hospital

**Name:** Shao-Bin Cheng, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M9613

- Name: Carcinoma, Hepatocellular

- Relevance: LOW

- As Found: Unknown

- ID: M11113

- Name: Liver Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11103

- Name: Liver Cirrhosis

- Relevance: HIGH

- As Found: Liver Cirrhosis

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Cirrhosis

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008103

- Term: Liver Cirrhosis

- ID: D000005355

- Term: Fibrosis

### Intervention Browse Module - Ancestors

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014803

- Term: Vitamin B Complex

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: LOW

- As Found: Unknown

- ID: M23026

- Name: Vitamin B 6

- Relevance: HIGH

- As Found: Health Outcomes

- ID: M14583

- Name: Pyridoxal

- Relevance: HIGH

- As Found: Health Outcomes

- ID: M14589

- Name: Pyridoxine

- Relevance: HIGH

- As Found: Health Outcomes

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

- ID: T474

- Name: Vitamin B6

- Relevance: HIGH

- As Found: Health Outcomes

- ID: T459

- Name: Pyridoxal

- Relevance: HIGH

- As Found: Health Outcomes

- ID: T461

- Name: Pyridoxine

- Relevance: HIGH

- As Found: Health Outcomes

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000025101

- Term: Vitamin B 6

- ID: D000011730

- Term: Pyridoxal

- ID: D000011736

- Term: Pyridoxine

### Misc Info Module

- Version Holder: 2024-05-24
