Vitamin B6 Aids in Treating Inflammatory Bowel Disease

NCT06512441 | Recruiting DMC

• 1 other identifier: VitB6
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

VitaminB6; treatment

Outcome Measures

Primary Outcomes (1)

• Clinical remission rate

  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 Outcomes (3)

• Disease activity score of IBD patients

  Through study completion, an average of 6 months .

• Histological remission

  Through study completion, an average of 6 months .

• Clinical response

  Through study completion, an average of 6 months .

Study Arms (2)

Experimental：VitaminB6 group

EXPERIMENTAL

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; Drug: Placebo

Placebo Comparator:Control group

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

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.

Also known as: Treatment

Experimental：VitaminB6 group; Placebo Comparator:Control group

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.

Also known as: Control

Experimental：VitaminB6 group; Placebo Comparator:Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Vitamin B 6; Therapeutics

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhaoshen Li

  The First Affiliated Hospital of Naval Medical University

  PRINCIPAL INVESTIGATOR

• Shu Zhu

  The University of Science and Technology of China

  STUDY DIRECTOR

Central Study Contacts

Zhaoshen Li

CONTACT

+86-21-25070552; zhaoshenlismmu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind randomized controlled trial involving patients and healthcare providers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: June 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

CN (1)