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

May 17, 2014 updated by: Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

900

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 Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200001
        • Recruiting
        • Shanghai Institute of Digestive Disease
        • Principal Investigator:
          • Jing-Yuan Fang, MD. Ph D.

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Ca plus vit D
elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements for 3 years
Drug: Ca plus vit D
elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements
Other Names:
  • Caltrate
Placebo Comparator: placebo
identical-appearing placebo supplements for 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after calcium plus vitamin D intervention.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The recurrence rates of advanced colorectal adenoma (A-CRA) after calcium plus vitamin D intervention.
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Time Frame
changes in serum calcium
Time Frame: baseline and 3 years
baseline and 3 years
changes in serum 25-(OH) Vit D level
Time Frame: baseline and 3 years
baseline and 3 years
the incidence of colorectal cancer (CRC) after calcium plus vitamin D intervention
Time Frame: 3 years
3 years
changes in clinical symptoms scores (positive iFOBT, diarrhea, or constipation et al)
Time Frame: baseline and 3 years
baseline and 3 years
differences in the number, location, size and histological subtype of CRA
Time Frame: baseline and 3 years
baseline and 3 years
changes in routine blood count, urine and stool routine test, liver and kidney functions, etc
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

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

March 1, 2014

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

May 17, 2014

First Submitted That Met QC Criteria

May 17, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 17, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014BAI09B05

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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