Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD

NCT ID: NCT05701501

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-02-01

Brief Summary

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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

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Vitamin B5 Tablets

Intervention Type DRUG

The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

The control group was given placebo tablets of the same type based on the standard IBD treatment.

Interventions

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Vitamin B5 Tablets

The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.

Intervention Type DRUG

placebo

The control group was given placebo tablets of the same type based on the standard IBD treatment.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Science and Technology of China

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of gastroenterology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoshen Li, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Shu Zhu, PhD

Role: STUDY_DIRECTOR

The University of Science and Technology of China

Locations

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Changhai Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoshen Li, PhD, MD

Role: CONTACT

+86-21-25070552

Facility Contacts

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zhaoshen Li, MD

Role: primary

86-21-81873241

Other Identifiers

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VitB5

Identifier Type: -

Identifier Source: org_study_id

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