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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02066688
First Posted: February 19, 2014
Last Update Posted: February 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine
  Purpose
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.

Condition Intervention Phase
Colorectal Neoplasms Drug: folic acid Drug: folic acid calcium vitamin D3 Drug: calcium Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomize Controlled Trial of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine:

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. [ Time Frame: baseline and 3 years ]

Secondary Outcome Measures:
  • the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention. [ Time Frame: baseline and 3 years ]
  • changes in serum calcium [ Time Frame: baseline and 3 years ]
  • changes in serum FA [ Time Frame: baseline and 3 years ]
  • the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention. [ Time Frame: 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 ]
  • differences in Histological types of CRA OR CRC [ Time Frame: baseline and 3 years ]

Other Outcome Measures:
  • Changes in routine blood count, urine and stool routine test, liver and kidney functions [ Time Frame: baseline and 3 years ]

Estimated Enrollment: 2400
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066688


Contacts
Contact: Jing-Yuan Fang, M.D.,Ph D. fangjingyuan_new@163.com
Contact: Ying-xuan Chen, M.D.,Ph D. yingxuanchen71@126.com

Locations
China
Renji Hospital Recruiting
Shanghai, China, 200001
Contact: Jing-yuan Fang, MD,Ph D.       jingyuanfang2007@126.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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
  More Information

Responsible Party: Jing-yuan Fang, MD, Ph. D, Director of Department of Gastroenterology, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02066688     History of Changes
Other Study ID Numbers: SQ2011SF12RJ
SQ2011SF12-20121010 ( Registry Identifier: Ying-xuan Chen )
First Submitted: February 17, 2014
First Posted: February 19, 2014
Last Update Posted: February 20, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Folic Acid
Calcium, Dietary
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hematinics