Vitamin B6 Aids in Treating Inflammatory Bowel Disease

July 16, 2024 updated by: Zhaoshen Li, Changhai Hospital

Vitamin B6 Assists in the Treatment of Inflammatory Bowel Disease

Patients with IBD are randomized to oral administration of VitaminB6 and placebo based on the standard treatment, exploring whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect of IBD patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Inflammatory bowel disease (IBD) is a group of chronic idiopathic inflammatory intestinal diseases, mainly including ulcerative colitis and Crohn's disease, with increasing incidence in China and worldwide. The disease currently lacks a cure, with many patients experiencing relapses and requiring surgery, and an increased risk of cancer. There is substantial evidence suggesting a close relationship between body vitamin B6 levels and IBD.Thus,we design this clinical trial that aims to explore whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with IBD according to the consensus on the diagnosis and treatment of inflammatory bowel disease (Beijing, 2018, DOI: 10.19538/j.nk2018090106);
  • Have complete medical history data;
  • Volunteer to participate in this clinical trial and sign the informed consent form.

Exclusion Criteria:

  • Patients with peripheral neuropathy;
  • Patients with abdominal abscess, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
  • Patients with other autoimmune diseases, hematologic disorders, tumors, acute infections, severe liver or kidney dysfunction, severe conditions such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, cirrhosis, kidney disease, and psychiatric disorders;
  • Patients who have taken vitamin B6 tablets in the past 3 months;
  • Patients with a history of substance abuse;
  • Pregnant or lactating women, or those planning to become pregnant within the next 6 months;
  • Neurological disorders such as Alzheimer's disease, stroke, Parkinson's disease;
  • Participation in other clinical trials in the past 6 months;
  • Incomplete medical records (including gender, age, diagnosis, colonoscopy results, pathological diagnosis results, and other demographic data);
  • Currently taking: levodopa, phenobarbital, phenytoin sodium.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental：VitaminB6 group
Based on the standard treatment，VitaminB6 （10mg/tablet）is given orally once a day,one tablet each time,for 3 weeks.
Drug: Vitamin B6 Tablets
The experimental group was given a Vitamin B6 tablet（10mg/tablet）once a day for 3weeks, besides of the standard IBD treatment.
Other Names:
  • Treatment
Drug: Placebo
The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.
Other Names:
  • Control
Placebo Comparator: Placebo Comparator:Control group
Based on the standard treatment，the same type of placebo tablets are given orally once a day,one tablet each time,for 3 weeks.
Drug: Vitamin B6 Tablets
The experimental group was given a Vitamin B6 tablet（10mg/tablet）once a day for 3weeks, besides of the standard IBD treatment.
Other Names:
  • Treatment
Drug: Placebo
The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission rate
Time Frame: Through study completion, an average of 6 months .
To evaluate the improvement effect of clinical remission rate (Mayo score ≤ 2 points and no single sub-score>1 point; CDAl score<150) in IBD patients after 3 weeks of oral Vitamin B6 while taking routine treatment.
Through study completion, an average of 6 months .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity score of IBD patients
Time Frame: Through study completion, an average of 6 months .
Modified Mayo score or CDAl score
Through study completion, an average of 6 months .
Histological remission
Time Frame: Through study completion, an average of 6 months .
Based on the Geboes scale. No or slight increase of chronic inflammatory infiltration in lamina propria, no neutrophils in lamina propria or epithelium, no persistent clinicai response of erosion, ulcer or granulation tissue.
Through study completion, an average of 6 months .
Clinical response
Time Frame: Through study completion, an average of 6 months .
Modified Mayo score decreased by 2 points and 30% from baseline+rectal bleeding score decreased by 1 point or absolute rectal bleeding score decreased by 1 point.
Through study completion, an average of 6 months .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Zhaoshen Li, The First Affiliated Hospital of Naval Medical University
  • Study Director: Shu Zhu, The University of Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitB6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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