Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
- Conditions
- Colorectal Neoplasms
- Interventions
- Registration Number
- NCT02066688
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
Folic acid (FA) and its derivatives (folate) which play a role in nucleotide synthesis and methylation reactions as well as calcium and vitamin D are assumed to be effective in the prevention of colorectal polyps and Colorectal cancer (CRC). The aim of this study is to investigate the roles of FA as well as calcium and vitamin D in the prevention of CRC.
- Detailed Description
Colorectal cancer (CRC) affects approximately one million people each year with a five-year survival rate of 62% . Considerable interest has recently been focused on the relationship between the chemoprevention of colorectal polyps/CRA and CRC. Therefore, the use of nutritional compounds which are usually less afflicted with the risk of severe side effects for colorectal adenoma (CRA) prevention and health maintenance is an emerging field.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2400
- individuals aged 50-80 years
- Patients had undergone complete colonoscopy with no adenoma found
- Those who voluntarily sign the consent form after being fully informed and understanding the purpose and procedures of the study, characters of the disease, effect of medications, methods of related examinations, and potential risk/benefits of the study
- Patients who are hypersensitive or intolerant to the drugs
- Patients who are intolerant to another colonoscopy examination
- Pregnant women, woman during breast-feeding period, or women with expect pregnancy
- Patients with diabetes mellitus, severe heart or renal disease，or cancer history
- Patients with malignant neoplasm, or suspicious colorectal cancer
- Patients who are not able to cooperate
- Individuals who are involved in designing, planning or performing this experiment
- Patients with medical conditions who are not appropriate to participate the study
- Patients who are take aspirin or cyclooxygenase 2 inhibitor （COX2）.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description FA+Ca folic acid calcium vitamin D3 Patients receive oral folic acid pill 1 mg+ calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects(FA+Ca arm). Ca calcium Patients receive oral calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects (Ca Arm). FA folic acid Patients receive oral folic acid pill 1 mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects (FA Arm).
- Primary Outcome Measures
Name Time Method The primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention. baseline and 3 years
- Secondary Outcome Measures
Name Time Method the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention. baseline and 3 years changes in serum calcium baseline and 3 years changes in serum FA baseline and 3 years the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention. baseline and 3 years changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al) baseline and 3 years differences in Histological types of CRA OR CRC baseline and 3 years
Trial Locations
- Locations (1)
Renji Hospital
🇨🇳Shanghai, China