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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ca plus vit D

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

Group Type EXPERIMENTAL

Ca plus vit D

Intervention Type DRUG

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

placebo

identical-appearing placebo supplements for 3 years

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Ca plus vit D

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

Intervention Type DRUG

Other Intervention Names

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Caltrate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes