Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
NCT ID: NCT02066688
Last Updated: 2014-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
2400 participants
INTERVENTIONAL
2013-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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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).
folic acid
Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
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).
folic 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 .
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).
calcium
calcium 1200mg/d + vitamin D3 250 IU/d daily supplements
blank control group
Patients receive oral placebo once daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
No interventions assigned to this group
Interventions
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folic acid
Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
folic 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 .
calcium
calcium 1200mg/d + vitamin D3 250 IU/d daily supplements
Eligibility Criteria
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Inclusion Criteria
* 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 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）.
50 Years
80 Years
ALL
Yes
Sponsors
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Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Jing-yuan Fang, MD, Ph. D
Director of Department of Gastroenterology
Principal Investigators
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Jing-yuan Fang, MD., Ph D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Locations
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Renji Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SQ2011SF12-20121010
Identifier Type: REGISTRY
Identifier Source: secondary_id
SQ2011SF12RJ
Identifier Type: -
Identifier Source: org_study_id
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