Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.
- Registration Number
- NCT06649825
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
This study aimed to investigate the efficacy of vitamin B1 in patients with familial adenomatous polyposis, and to determine the inhibitory effect of vitamin B1 on the size and number of colorectal adenomas by administering oral vitamin B1 therapy for 1 year and colonoscopy follow-up every 3 months
- Detailed Description
We will mark a region with a diameter of no more than 5 cm, containing at least 3 polyps, each with a diameter of 5-15 mm. Continuous video recording will be conducted throughout the colonoscopy procedure to provide baseline reference images of the colorectal polyps. Patients with familial adenomatous polyposis were given 100mg bid dose of vitamin B1 orally for one year, and colonoscopies were followed every 3 months to observe changes in the size and number of polyps in the designated area.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vitamin B1 Vitamin B1 -
- Primary Outcome Measures
Name Time Method Sum of polyp diameters in the delineated area 3 months The diameter of each polyp was assessed by two independent endoscopists and the average of two diameters perpendicular to each other was reported. The diameter of the polyp was determined with reference to the titanium clip, blood vessels and scar in the visual field.
- Secondary Outcome Measures
Name Time Method The number of polyps in the delineated area 3 months The number of polyps was assessed by two independent endoscopists, and disputes were decided by a third endoscopist
Levels of vitamin B1-associated metabolites, including TMP, TPP, TTP, and free thiamine, in blood and urine samples and in polyps outside the delineated area 3 months The content of vitamin B1 related metabolites was determined by liquid chromatography-tandem mass spectrometry
Trial Locations
- Locations (1)
Shanghai Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China