Inflammatory Bowel DiseasesNCT06512441
Vitamin B6 Aids in Treating Inflammatory Bowel Disease
A study testing Vitamin B6 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 VitaminB6 and placebo based on the standard treatment, exploring whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect of IBD patients. 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 B6 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Dec 2025
- 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
- Patients with peripheral neuropathy;
- Patients with abdominal abscess, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
- Patients with other autoimmune diseases, hematologic disorders, tumors, acute infections, severe liver or kidney dysfunction, severe conditions such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, cirrhosis, kidney disease, and psychiatric disorders;
- Patients who have taken vitamin B6 tablets in the past 3 months;
- Patients with a history of substance abuse;
- Pregnant or lactating women, or those planning to become pregnant within the next 6 months;
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- Neurological disorders such as Alzheimer's disease, stroke, Parkinson's disease;
- Participation in other clinical trials in the past 6 months;
- Incomplete medical records (including gender, age, diagnosis, colonoscopy results, pathological diagnosis results, and other demographic data);
- Currently taking: levodopa, phenobarbital, phenytoin sodium.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality
Zhaoshen Li, PhD, zhaoshenlismmu@gmail.com
About this study
Official title: Vitamin B6 Assists in the Treatment of Inflammatory Bowel Disease
Patients with IBD are randomized to oral administration of VitaminB6 and placebo based on the standard treatment, exploring whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect of IBD patients.
Read the detailed description
Inflammatory bowel disease (IBD) is a group of chronic idiopathic inflammatory intestinal diseases, mainly including ulcerative colitis and Crohn's disease, with increasing incidence in China and worldwide. The disease currently lacks a cure, with many patients experiencing relapses and requiring surgery, and an increased risk of cancer. There is substantial evidence suggesting a close relationship between body vitamin B6 levels and IBD.Thus,we design this clinical trial that aims to explore whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Vitamin B6 Tablets, Placebo
- Keywords
- VitaminB6, 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 B6 TabletsDrug
Also called Treatment
The experimental group was given a Vitamin B6 tablet（10mg/tablet）once a day for 3weeks, besides of the standard IBD treatment.
PlaceboDrug
Also called Control
The control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental：VitaminB6 group | Experimental | Based on the standard treatment，VitaminB6 （10mg/tablet）is given orally once a day,one tablet each time,for 3 weeks. Receives: Drug: Vitamin B6 Tablets; Drug: Placebo |
| Placebo Comparator:Control group | Placebo comparator | Based on the standard treatment，the same type of placebo tablets are given orally once a day,one tablet each time,for 3 weeks. Receives: Drug: Vitamin B6 Tablets; 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; CDAl score<150) in IBD patients after 3 weeks of oral Vitamin B6 while taking routine treatment.
Measured: Through study completion, an average of 6 months .
Secondary outcomes (3)
Disease activity score of IBD patients
Modified Mayo score or CDAl score
Measured: Through study completion, an average of 6 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 clinicai response of erosion, ulcer or granulation tissue.
Measured: Through study completion, an average of 6 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 6 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jun 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, Principal investigator, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical UniversityShu Zhu, Study director, The University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512441
- Sponsor's protocol ID
- VitB6
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin B6 Assists in the Treatment of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06512441
- Acronym / sponsor ID
- VitB6
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- VitaminB6, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Jul 2024 (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 VitaminB6 and placebo based on the standard treatment, exploring whether VitaminB6 can increasee the clinical remission rateand improve the treatment effect of IBD patients.
Detailed description
Inflammatory bowel disease (IBD) is a group of chronic idiopathic inflammatory intestinal diseases, mainly including ulcerative colitis and Crohn's disease, with increasing incidence in China and worldwide. The disease currently lacks a cure, with many patients experiencing relapses and requiring surgery, and an increased risk of cancer. There is substantial evidence suggesting a close relationship between body vitamin B6 levels and IBD.Thus,we design this clinical trial that aims to explore whether VitaminB6 can increasee the clinical remission rateand 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 |
|---|---|---|
| Experimental：VitaminB6 group | Experimental | Drug: Vitamin B6 Tablets, Drug: PlaceboBased on the standard treatment，VitaminB6 （10mg/tablet）is given orally once a day,one tablet each time,for 3 weeks. |
| Placebo Comparator:Control group | Placebo comparator | Drug: Vitamin B6 Tablets, Drug: PlaceboBased on the standard treatment，the same type of placebo tablets are given orally once a day,one tablet each time,for 3 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 (10 listed)
- Patients with peripheral neuropathy;
- Patients with abdominal abscess, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
- Patients with other autoimmune diseases, hematologic disorders, tumors, acute infections, severe liver or kidney dysfunction, severe conditions such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, cirrhosis, kidney disease, and psychiatric disorders;
- Patients who have taken vitamin B6 tablets in the past 3 months;
- Patients with a history of substance abuse;
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 B6 TabletsAlso: TreatmentThe experimental group was given a Vitamin B6 tablet（10mg/tablet）once a day for 3weeks, besides of the standard IBD treatment. | Drug | Experimental：VitaminB6 group, Placebo Comparator:Control group |
| PlaceboAlso: ControlThe control group was given a placebo tablet on the same type once a day for 3weeks, besides of the standard IBD treatment. | Drug | Experimental：VitaminB6 group, Placebo Comparator:Control group |
Primary outcome
Clinical remission rate
Time frame: Through study completion, an average of 6 months .
To evaluate the improvement effect of clinical remission rate (Mayo score ≤ 2 points and no single sub-score>1 point; CDAl score<150) in IBD patients after 3 weeks of oral Vitamin B6 while taking routine treatment.
3 secondary outcomes
Disease activity score of IBD patients
Time frame: Through study completion, an average of 6 months .
Histological remission
Time frame: Through study completion, an average of 6 months .
Clinical response
Time frame: Through study completion, an average of 6 months .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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 principal investigator
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Shu Zhu 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 B6 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 10 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 22 Jul 2024. 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 (+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 6 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 22 Jul 2024.