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

Primary Purpose

Colorectal Adenoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ca plus vit D
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Adenoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shanghai Institute of Digestive DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ca plus vit D

placebo

Arm Description

elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements for 3 years

identical-appearing placebo supplements for 3 years

Outcomes

Primary Outcome Measures

The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after calcium plus vitamin D intervention.

Secondary Outcome Measures

The recurrence rates of advanced colorectal adenoma (A-CRA) after calcium plus vitamin D intervention.

Full Information

First Posted
May 17, 2014
Last Updated
May 17, 2014
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT02143505
Brief Title
Study of Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas Recurrence
Official Title
Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas Recurrence:a Prospective, Randomized, Placebo-controlled, Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ca plus vit D
Arm Type
Experimental
Arm Description
elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements for 3 years
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
identical-appearing placebo supplements for 3 years
Intervention Type
Drug
Intervention Name(s)
Ca plus vit D
Other Intervention Name(s)
Caltrate
Intervention Description
elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The recurrence rates of advanced colorectal adenoma (A-CRA) after calcium plus vitamin D intervention.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
changes in serum calcium
Time Frame
baseline and 3 years
Title
changes in serum 25-(OH) Vit D level
Time Frame
baseline and 3 years
Title
the incidence of colorectal cancer (CRC) after calcium plus vitamin D intervention
Time Frame
3 years
Title
changes in clinical symptoms scores (positive iFOBT, diarrhea, or constipation et al)
Time Frame
baseline and 3 years
Title
differences in the number, location, size and histological subtype of CRA
Time Frame
baseline and 3 years
Title
changes in routine blood count, urine and stool routine test, liver and kidney functions, etc
Time Frame
baseline and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing-Yuan Fang, M.D., Ph.D
Phone
86-21-53882450
Email
fangjingyuan_new@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying-Xuan Chen, M.D., Ph.D
Phone
86-21-63200874
Email
yingxuanchen71@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-Yuan Fang, M.D., Ph.D
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Institute of Digestive Disease
City
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jing-yuan Fang, MD. Ph D.

12. IPD Sharing Statement

Learn more about this trial

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

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