Clinical trial NCT02143505: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colorectal Adenoma
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2014-05-21
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after calcium plus vitamin D intervention.
timeFrame: 3 years
Secondary outcomes:
measure: The recurrence rates of advanced colorectal adenoma (A-CRA) after calcium plus vitamin D intervention.
timeFrame: 3 years
Other outcomes:
measure: changes in serum calcium
timeFrame: baseline and 3 years
measure: changes in serum 25-(OH) Vit D level
timeFrame: baseline and 3 years
measure: the incidence of colorectal cancer (CRC) after calcium plus vitamin D intervention
timeFrame: 3 years
measure: changes in clinical symptoms scores (positive iFOBT, diarrhea, or constipation et al)
timeFrame: baseline and 3 years
measure: differences in the number, location, size and histological subtype of CRA
timeFrame: baseline and 3 years
measure: changes in routine blood count, urine and stool routine test, liver and kidney functions, etc
timeFrame: baseline and 3 years
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Digestive Disease
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jing-Yuan Fang, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: