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

February 18, 2014 updated by: Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine

A Randomize Controlled Trial of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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）.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: folic acid
Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
Experimental: 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).
Drug: 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 .
Experimental: 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).
Drug: calcium
calcium 1200mg/d + vitamin D3 250 IU/d daily supplements
Placebo Comparator: blank control group
Patients receive oral placebo once daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline and 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in serum calcium
Time Frame: baseline and 3 years
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
baseline and 3 years
changes in serum FA
Time Frame: baseline and 3 years
baseline and 3 years
the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention.
Time Frame: baseline and 3 years
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
baseline and 3 years
differences in Histological types of CRA OR CRC
Time Frame: baseline and 3 years
baseline and 3 years

Other Outcome Measures

Outcome Measure
Time Frame
Changes in routine blood count, urine and stool routine test, liver and kidney functions
Time Frame: baseline and 3 years
baseline and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Ministry of Science and Technology of the People´s Republic of China

Investigators

  • Principal Investigator: Jing-yuan Fang, MD., Ph D., Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 17, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Estimate)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQ2011SF12RJ
  • SQ2011SF12-20121010 (Registry Identifier: Ying-xuan Chen)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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