Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD

Clinical Study of Vitamin B5 in Adjuvant Treatment of Inflammatory Bowel Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Drug: Vitamin B5 Tablets; Drug: placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhaoshen Li, PhD, MD; Phone Number: +86-21-25070552; Email: zhaoshenlismmu@gmail.com

Study Locations

• China
  • Shanghai, China, 200433
    • Recruiting
    • Changhai Hospital
    • Contact: zhaoshen Li, MD; Phone Number: 86-21-81873241; Email: zhaoshenlismmu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin B5 group; Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks.	Drug: Vitamin B5 Tablets; The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.
Placebo Comparator: Control group; 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.	Drug: placebo; The control group was given placebo tablets of the same type based on the standard IBD treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission rate	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.	Through study completion, an average of 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity score of IBD patients	Modified Mayo score or CDAI score	Through study completion, an average of 12 months.
Histological remission	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.	Through study completion, an average of 12 months.
Clinical response	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.	Through study completion, an average of 12 months.

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The University of Science and Technology of China
• Investigators: Principal Investigator: Zhaoshen Li, MD, Changhai Hospital; Study Director: Shu Zhu, PhD, The University of Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin B5,treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Pantothenic Acid
• Other Study ID Numbers: VitB5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No