Using Vitamin B6 to Treat Inflammatory Bowel Disease

Vitamin B6 Assists in the Treatment of Inflammatory Bowel Disease

This study is testing if taking Vitamin B6 can help people with inflammatory bowel disease feel better and improve their treatment results.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06512441 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of oral Vitamin B6 on patients with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. Participants will be randomly assigned to receive either Vitamin B6 or a placebo, with the aim of determining if Vitamin B6 can enhance clinical remission rates and improve treatment outcomes. The study is motivated by evidence suggesting a link between Vitamin B6 levels and IBD severity. The trial will involve careful monitoring of patient responses to the treatment over a specified period.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with inflammatory bowel disease who meet the inclusion criteria and are willing to participate.

Not a fit: Patients with severe complications or other significant health issues, such as peripheral neuropathy or autoimmune diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for managing inflammatory bowel disease.

How similar studies have performed: While there is existing evidence linking Vitamin B6 to IBD, this specific approach is novel and has not been extensively tested in clinical trials.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhaoshen Li — The First Affiliated Hospital of Naval Medical University
• Study coordinator: Zhaoshen Li

Conditions Inflammatory Bowel Diseases; VitaminB6; treatment