Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Vitamin B5 Tablets; Drug: placebo

• Registration Number: NCT05701501
• Lead Sponsor: Changhai Hospital

Brief Summary

Patients with IBD are randomized to oral administration of vitamin B5 and placebo based on the standard treatment, exploring whether Vitamin B5 can increase the clinical remission rate of IBD patients and improve the treatment effect.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Study Start: 2023-02-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Hemophilic patients;
• There are abdominal abscesses, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
• Other autoimmune diseases, hematological diseases, tumors, acute infection, severe liver and kidney insufficiency, serious diseases such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, liver cirrhosis, kidney disease and mental diseases;
• Take calcium pantothenate preparation in recent 3 months;
• Have a history of abuse of psychoactive substances;
• Pregnant or lactating women, or plan to be pregnant in the next 6 months;
• Nervous system diseases: such as Alzheimer's disease, stroke, Parkinson's disease;
• Participate in other clinical trials in the past 6 months;
• Incomplete medical record information (including gender, age, diagnosis information, colonoscopy results, pathological diagnosis results and other demographic data)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin B5 group	Vitamin B5 Tablets	Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks.
Control group	placebo	Based on the standard IBD treatment, the same type of placebo tablets are given orally three times a day, four tablets each time, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Clinical remission rate	Through study completion, an average of 12 months.	To evaluate the improvement effect of clinical remission rate (Mayo score ≤ 2 points and no single sub-score\>1 point; CDAI score\<150) in IBD patients after 12 weeks of oral Vitamin B5 while taking routine treatment.

Secondary Outcome Measures

Name	Time	Method
Disease activity score of IBD patients	Through study completion, an average of 12 months.	Modified Mayo score or CDAI score
Histological remission	Through study completion, an average of 12 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 clinical response of erosion, ulcer or granulation tissue.
Clinical response	Through study completion, an average of 12 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.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China