Clinical trial NCT02066688: Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
Official title: A Randomize Controlled Trial of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colorectal Neoplasms
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2014-02-19
Enrollment: 2400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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）.

Primary outcomes:
measure: The primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention.
timeFrame: baseline and 3 years
Secondary outcomes:
measure: the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention.
timeFrame: baseline and 3 years
measure: changes in serum calcium
timeFrame: baseline and 3 years
measure: changes in serum FA
timeFrame: baseline and 3 years
measure: the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention.
timeFrame: baseline and 3 years
measure: changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al)
timeFrame: baseline and 3 years
measure: differences in Histological types of CRA OR CRC
timeFrame: baseline and 3 years
Other outcomes:
measure: Changes in routine blood count, urine and stool routine test, liver and kidney functions
timeFrame: baseline and 3 years
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jing-yuan Fang, MD., Ph D.
role: PRINCIPAL_INVESTIGATOR
References: