Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
A Randomize Controlled Trial of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer
2 other identifiers
interventional
2,400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 20, 2014
February 1, 2014
2.9 years
February 17, 2014
February 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention.
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
- +1 more secondary outcomes
Other Outcomes (1)
Changes in routine blood count, urine and stool routine test, liver and kidney functions
baseline and 3 years
Study Arms (4)
FA
EXPERIMENTALPatients receive oral folic acid pill 1 mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects (FA Arm).
FA+Ca
EXPERIMENTALPatients 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).
Ca
EXPERIMENTALPatients 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).
blank control group
PLACEBO COMPARATORPatients receive oral placebo once daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
Interventions
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 .
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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）.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renji Hospital
Shanghai, 200001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing-yuan Fang, MD., Ph D.
Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Gastroenterology
Study Record Dates
First Submitted
February 17, 2014
First Posted
February 19, 2014
Study Start
January 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2017
Last Updated
February 20, 2014
Record last verified: 2014-02