Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701501
• Other study ID #: VitB5
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: June 2023
• Source: Changhai Hospital
• Contact: Zhaoshen Li, PhD, MD
• Phone: +86-21-25070552
• Email: zhaoshenlismmu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Vitamin B5 Tablets
The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.
• placebo
The control group was given placebo tablets of the same type based on the standard IBD treatment.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Changhai Hospital	The University of Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease activity score of IBD patients	Modified Mayo score or CDAI score	Through study completion, an average of 12 months.
Secondary	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.
Secondary	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.