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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02066688
• Other study ID #: SQ2011SF12RJ
• Secondary ID: SQ2011SF12-20121
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 17, 2014
• Last updated: February 18, 2014
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: February 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jing-Yuan Fang, M.D.,Ph D.
• Email: fangjingyuan_new[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• folic acid
Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
• 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 .
• calcium
calcium 1200mg/d + vitamin D3 250 IU/d daily supplements

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in routine blood count, urine and stool routine test, liver and kidney functions		baseline and 3 years	Yes
Primary	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	No
Secondary	the incidence of advanced colorectal adenoma (A-CRA) after Folic acid, calcium and vitamin D intervention.		baseline and 3 years	No
Secondary	changes in serum calcium		baseline and 3 years	Yes
Secondary	changes in serum FA		baseline and 3 years	Yes
Secondary	the incidence of colorectal cancer (CRC) after Folic acid, calcium and vitamin D intervention.		baseline and 3 years	No
Secondary	changes in clinical symptoms scores (positive immunochemical fecal occult blood test (iFOBT), diarrhea, or constipation et al)		baseline and 3 years	No
Secondary	differences in Histological types of CRA OR CRC		baseline and 3 years	No