RecruitingNot ApplicableNCT06512441

Vitamin B6 Aids in Treating Inflammatory Bowel Disease

Vitamin B6 Assists in the Treatment of Inflammatory Bowel Disease


Sponsor

Changhai Hospital

Enrollment

220 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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.

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Interventions

DRUGVitamin B6 Tablets

The experimental group was given a Vitamin B6 tablet(10mg/tablet)once a day for 3weeks, besides of the standard IBD treatment.

DRUGPlacebo

The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.


Locations(1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

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NCT06512441


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