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Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
folic acid
folic acid calcium vitamin D3
calcium
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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）.

Sites / Locations

  • Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

FA

FA+Ca

Ca

blank control group

Arm Description

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).

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).

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).

Patients receive oral placebo once daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.

Outcomes

Primary Outcome Measures

The primary objective of this study is to investigate the incidence of colorectal adenoma (CRA) after Folic acid, calcium and vitamin D intervention.

Secondary Outcome Measures

the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention.
changes in serum calcium
changes in serum FA
the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention.
changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al)
differences in Histological types of CRA OR CRC

Full Information

First Posted
February 17, 2014
Last Updated
February 18, 2014
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT02066688
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FA
Arm Type
Experimental
Arm Description
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).
Arm Title
FA+Ca
Arm Type
Experimental
Arm Description
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).
Arm Title
Ca
Arm Type
Experimental
Arm Description
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).
Arm Title
blank control group
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo once daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
Intervention Type
Drug
Intervention Name(s)
folic acid
Intervention Description
Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
Intervention Type
Drug
Intervention Name(s)
folic acid calcium vitamin D3
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
calcium
Intervention Description
calcium 1200mg/d + vitamin D3 250 IU/d daily supplements
Primary Outcome Measure Information:
Title
The 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
Secondary Outcome Measure Information:
Title
the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention.
Time Frame
baseline and 3 years
Title
changes in serum calcium
Time Frame
baseline and 3 years
Title
changes in serum FA
Time Frame
baseline and 3 years
Title
the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention.
Time Frame
baseline and 3 years
Title
changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al)
Time Frame
baseline and 3 years
Title
differences in Histological types of CRA OR CRC
Time Frame
baseline and 3 years
Other Pre-specified Outcome Measures:
Title
Changes in routine blood count, urine and stool routine test, liver and kidney functions
Time Frame
baseline and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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）.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing-Yuan Fang, M.D.,Ph D.
Email
fangjingyuan_new@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying-xuan Chen, M.D.,Ph D.
Email
yingxuanchen71@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-yuan Fang, MD., Ph D.
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-yuan Fang, MD,Ph D.
Email
jingyuanfang2007@126.com

12. IPD Sharing Statement

Learn more about this trial

Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer

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