A Randomize Controlled Trial of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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）.
研究组 & 干预措施
FA
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).
干预措施: folic acid (Drug)
FA+Ca
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).
干预措施: folic acid calcium vitamin D3 (Drug)
Ca
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).
干预措施: calcium (Drug)
结局指标
主要结局
The primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention.
时间窗: baseline and 3 years
次要结局
- 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)
研究者
Jing-yuan Fang, MD, Ph. D
Director of Department of Gastroenterology
Shanghai Jiao Tong University School of Medicine