Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06649825

Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

About this study

The investigators 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a confirmed diagnosis of classical familial adenomatous polyposis (FAP) based on colonoscopy, histopathology, and genetic testing.
  • Aged between 18 and 80 years, with no restriction on gender.
  • No history of total colectomy, with remaining bowel segments available for evaluation.
  • Presence of more than 10 adenomatous polyps in the colon or rectum.
  • Normal liver and kidney function.
  • Willing to participate in vitamin B1 therapy and commit to regular follow-up appointments.

Exclusion criteria

  • Use of medications for more than one week in the past three months, or inability to avoid continuous use during the study period, that may affect colorectal polyps, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), ω-3 polyunsaturated fatty acids, rapamycin, and curcumin.
  • Use of medications for more than one week in the past three months, or inability to avoid continuous use during the study period, that may affect vitamin B1 absorption, metabolism, or excretion, including aminoglycoside antibiotics, thiazide diuretics, oral contraceptives, antiepileptic drugs, and antituberculosis drugs.
  • Attenuated familial adenomatous polyposis (AFAP).
  • Allergy to vitamin B1.
  • Contraindications to vitamin B1, such as liver or kidney dysfunction, or severe neuropsychiatric disorders.
  • History of total colectomy, with no remaining bowel segments.
  • Pregnant or breastfeeding individuals.
  • Presence of advanced colorectal cancer or metastatic cancer in other locations.
  • Previous radiotherapy, chemotherapy, or tumor immunotherapy.
  • History of alcohol or other substance abuse.

Treatment and study plan

vitamin B1

Drug

Vitamin B1 tablets, 100mg bid, taken orally for one year

Primary outcomes

  1. Sum of polyp diameters in the delineated area

    Time frame: 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 outcomes

  1. The number of polyps in the delineated area

    Time frame: 3 months

    The number of polyps was assessed by two independent endoscopists, and disputes were decided by a third endoscopist

  2. 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

    Time frame: 3 months

    The content of vitamin B1 related metabolites was determined by liquid chromatography-tandem mass spectrometry

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Evaluation of the Efficacy of Vitamin B1 in Patients With Familial Adenomatous Polyposis: An Exploratory Study

Acronym: VitB1; FAP

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.