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NCT Number: NCT06512441

Vitamin B6 Aids in Treating 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Zhaoshen Li, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin B6 Tablets

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Disease activity score of IBD patients

    Time frame: Through study completion, an average of 6 months .

    Modified Mayo score or CDAl score

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhaoshen Li

CONTACT

[email protected]

+86-21-25070552

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Vitamin B6 Assists in the Treatment of Inflammatory Bowel Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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