Back to resultsClinical Study of Vitamin B5 in Adjuvant Treatment of IBD
Primary Purpose
Inflammatory Bowel Diseases
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vitamin B5 Tablets
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Vitamin B5,treatment
Eligibility Criteria
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)
Sites / Locations
- Changhai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin B5 group
Control group
Arm Description
Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Disease activity score of IBD patients
Modified Mayo score or CDAI score
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.
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.
Full Information
NCT ID
NCT05701501
First Posted
January 18, 2023
Last Updated
June 13, 2023
Sponsor
Changhai Hospital
Collaborators
The University of Science and Technology of China
1. Study Identification
Unique Protocol Identification Number
NCT05701501
Brief Title
Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD
Official Title
Clinical Study of Vitamin B5 in Adjuvant Treatment of Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
The University of Science and Technology of China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Vitamin B5,treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin B5 group
Arm Type
Experimental
Arm Description
Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin B5 Tablets
Intervention Description
The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
The control group was given placebo tablets of the same type based on the standard IBD treatment.
Primary Outcome Measure Information:
Title
Clinical remission rate
Description
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.
Time Frame
Through study completion, an average of 12 months.
Secondary Outcome Measure Information:
Title
Disease activity score of IBD patients
Description
Modified Mayo score or CDAI score
Time Frame
Through study completion, an average of 12 months.
Title
Histological remission
Description
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.
Time Frame
Through study completion, an average of 12 months.
Title
Clinical response
Description
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.
Time Frame
Through study completion, an average of 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoshen Li, PhD, MD
Phone
+86-21-25070552
Email
zhaoshenlismmu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, MD
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shu Zhu, PhD
Organizational Affiliation
The University of Science and Technology of China
Official's Role
Study Director
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhaoshen Li, MD
Phone
86-21-81873241
Email
zhaoshenlismmu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD
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