Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

NCT06649825 | Enrolling By Invitation DMC

• 1 other identifier: ShanghaiZhongshanEndoscopy2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Familial Adenomatous Polyposis (FAP)

Keywords

Familial adenomatous polyposis; thiamin

Outcome Measures

Primary Outcomes (1)

• Sum of polyp diameters in the delineated area

  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.

  3 months

Secondary Outcomes (2)

• The number of polyps in the delineated area

  3 months

• 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

Study Arms (1)

Vitamin B1

EXPERIMENTAL

Drug: Vitamin B1

Interventions

Vitamin B1 DRUG

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

Vitamin B1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Pinghong Zhou, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The data will be available after publication of the study
• Access Criteria: The shared data could be available by contacting Dr. Xin-Yang Liu at liu.xinyang@zs-hospital.sh.cn.

Locations

CN (1)