Vitamin B6 Aids in Treating Inflammatory Bowel Disease

Naval Military Medical University

Status: Enrolling

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Placebo; Drug: Vitamin B6 Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06512441

VitB6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups, including a placebo group

Experimental：VitaminB6 group

Experimental group

Description:

Based on the standard treatment，VitaminB6 （10mg/tablet）is given orally once a day,one tablet each time,for 3 weeks.

Treatment:

Drug: Placebo

Drug: Vitamin B6 Tablets

Placebo Comparator:Control group

Placebo Comparator group

Description:

Based on the standard treatment，the same type of placebo tablets are given orally once a day,one tablet each time,for 3 weeks.

Treatment:

Drug: Placebo

Drug: Vitamin B6 Tablets