Colorectal Neoplasms
Conditions
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.
Interventions
DRUGfolic acid
Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
DRUGfolic acid calcium vitamin D3
Patients receive oral folic acid 1mg + calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects .
DRUGcalcium
calcium 1200mg/d + vitamin D3 250 IU/d daily supplements
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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）.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention. | baseline and 3 years |
Other
| Measure | Time frame |
|---|---|
| Changes in routine blood count, urine and stool routine test, liver and kidney functions | baseline and 3 years |
Countries
China
Contacts
Primary ContactJing-Yuan Fang, M.D.,Ph D.
Backup ContactYing-xuan Chen, M.D.,Ph D.
Outcome results
None listed