Trial record 14 of 136 for:    vitamin d | colon cancer

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Shanghai Jiao Tong University School of Medicine
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT02066688
First received: February 17, 2014
Last updated: February 18, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • changes in serum calcium [ Time Frame: baseline and 3 years ] [ Designated as safety issue: Yes ]
  • changes in serum FA [ Time Frame: baseline and 3 years ] [ Designated as safety issue: Yes ]
  • the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention. [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
  • changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al) [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
  • differences in Histological types of CRA OR CRC [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 17, 2014
Last Updated: February 18, 2014
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on August 26, 2014