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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,400
Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
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 .
calcium 1200mg/d + vitamin D3 250 IU/d daily supplements
Renji Hospital
Shanghai, China
RECRUITINGThe primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention.
Time frame: baseline and 3 years
the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention.
Time frame: baseline and 3 years
changes in serum calcium
Time frame: baseline and 3 years
changes in serum FA
Time frame: baseline and 3 years
the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention.
Time frame: baseline and 3 years
changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al)
Time frame: baseline and 3 years
differences in Histological types of CRA OR CRC
Time frame: baseline and 3 years
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