Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Colorectal Neoplasms

Treatments: Drug: folic acid; Drug: folic acid calcium vitamin D3; Drug: calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT02066688

SQ2011SF12RJ

SQ2011SF12-20121010 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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）.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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2,400 participants in 4 patient groups, including a placebo group

FA

Experimental group

Description:

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).

Treatment:

Drug: folic acid

FA+Ca

Experimental group

Description:

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).

Treatment:

Drug: folic acid calcium vitamin D3

Ca

Experimental group

Description:

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).

Treatment:

Drug: calcium

blank control group

Placebo Comparator group

Description:

Patients receive oral placebo once daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.