Study of Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas Recurrence

Colorectal Adenoma Clinical Trial

Official title:

Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas Recurrence:a Prospective, Randomized, Placebo-controlled, Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02143505
• Other study ID #: 2014BAI09B05
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 17, 2014
• Last updated: May 17, 2014
• Start date: March 2014
• Est. completion date: February 2019

Study information

• Verified date: May 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jing-Yuan Fang, M.D., Ph.D
• Phone: 86-21-53882450
• Email: fangjingyuan_new[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Calcium plus vitamin D may be effective in the prevention of colorectal adenoma recurrence. The aim of this study is to investigate the effect of supplementation with calcium plus vitamin D on the recurrence of colorectal adenomas.

Description:

Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated. Since laboratory and epidemiologic evidence suggests that calcium or vitamin D may help prevent colorectal adenomas, we conduct a randomized, placebo-controlled, prospective clinical trial to study the effect and safety of calcium plus vitamin D supplementation in prevention of colorectal adenomas recurrence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: February 2019
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Individuals aged 18-65years

• Individuals who had at least one histologically confirmed colorectal adenoma removed within three months before recruitment

• Individuals without a history of familial polyposis

• 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

• Patients with hypercalcemia or urolithiasis

• Pregnant women, women during breast-feeding period, or women with expect pregnancy

• Patients with diabetes mellitus, severe heart or renal disease, or cancer history

• Patients with a history of subtotal gastrectomy or partial bowel resection

• Patients who are not able to cooperate

• Individual who are involved in designing, planning or performing this clinical trial

• Patients with medical conditions who are not appropriate to participate the study

• Patients who are taking aspirin, NSAIDs or COX2 inhibitors

• Patients who are taking folic acid or Butyrate.

• Patients with IBD

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

• Adenoma
• Colorectal Adenoma

Intervention

Drug:
• Ca plus vit D
elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements

Locations

Country	Name	City	State
China	Shanghai Institute of Digestive Disease	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 serum calcium		baseline and 3 years	Yes
Other	changes in serum 25-(OH) Vit D level		baseline and 3 years	Yes
Other	the incidence of colorectal cancer (CRC) after calcium plus vitamin D intervention		3 years	No
Other	changes in clinical symptoms scores (positive iFOBT, diarrhea, or constipation et al)		baseline and 3 years	No
Other	differences in the number, location, size and histological subtype of CRA		baseline and 3 years	No
Other	changes in routine blood count, urine and stool routine test, liver and kidney functions, etc		baseline and 3 years	Yes
Primary	The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after calcium plus vitamin D intervention.		3 years	No
Secondary	The recurrence rates of advanced colorectal adenoma (A-CRA) after calcium plus vitamin D intervention.		3 years	No