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

Shanghai Jiao Tong University School of Medicine

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Colorectal Adenoma

Treatments

Drug: Ca plus vit D

Study type

Interventional

Funder types

Other

Identifiers

NCT02143505

2014BAI09B05

Details and patient eligibility

About

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.

Full 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.

Enrollment

900 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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