Inflammatory Bowel DiseasesNCT05701501
Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD
A study testing Vitamin B5 Tablets in people with Inflammatory Bowel Diseases, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Vitamin B5 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, 200433
zhaoshen Li, MD, 86-21-81873241, zhaoshenlismmu@gmail.com
About this study
Official title: 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Vitamin B5 Tablets, placebo
- Keywords
- Vitamin B5,treatment
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B5 TabletsDrug
The experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment.
placeboDrug
The control group was given placebo tablets of the same type based on the standard IBD treatment.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B5 group | Experimental | Based on the standard IBD treatment, Vitamin B5 (5mg/tablet) is given orally three times a day, four tablets each time, for 12 weeks. Receives: Drug: Vitamin B5 Tablets |
| Control group | Placebo comparator | 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 12 months.
Secondary outcomes (3)
Disease activity score of IBD patients
Modified Mayo score or CDAI score
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Science and Technology of China
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, MD, Principal investigator, Changhai HospitalShu Zhu, PhD, Study director, The University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701501
- Sponsor's protocol ID
- VitB5
- Status last verified
- Jun 2023
- First submitted
- 18 Jan 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Vitamin B5 in Adjuvant Treatment of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05701501
- Acronym / sponsor ID
- VitB5
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Vitamin B5,treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The University of Science and Technology of China
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin B5 group | Experimental | Drug: Vitamin B5 TabletsBased 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 comparator | Drug: placeboBased 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B5 TabletsThe experimental group was given Vitamin tablets (5mg/tablet) based on the standard IBD treatment. | Drug | Vitamin B5 group |
| placeboThe control group was given placebo tablets of the same type based on the standard IBD treatment. | Drug | Control group |
Primary outcome
Clinical remission rate
Time frame: 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.
3 secondary outcomes
Disease activity score of IBD patients
Time frame: Through study completion, an average of 12 months.
Histological remission
Time frame: Through study completion, an average of 12 months.
Clinical response
Time frame: Through study completion, an average of 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoshen Li, MD principal investigator
Changhai Hospital
Shu Zhu, PhD study director
The University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B5 Tablets in people with Inflammatory Bowel Diseases, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaoshen Li, PhD, MD (+86-21-25070552, zhaoshenlismmu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (time frame: Through study completion, an average of 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.