colorectal tumor
Conditions
Interventions
Daily use of supplements containing vitamin D (1,200 IU) and calcium (400 mg)
Daily use of supplements containing calcium (400 mg)
Sponsors
National Center for Global Health and Medicine, Clinical Research Center
Saitama Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who fulfill all the criteria below. 1) Age: 30 to 74 years old 2) Patients who had adenoma or early colorectal cancer, which is confirmed by either image-enhanced endoscopy or histological examination, removed endoscopically in a curative manner within past 3 years. For patients who received tumor resection in hospitals other than Saitama Red Cross hosiptal, the tumor histology needs to be verified by a relevant document. 3) Patients with clean colon confirmed by total colonoscopy that took 15 minutes or longer within 3 months
Exclusion criteria
Exclusion criteria: 1) Patients with familial polyposis coli, hereditary nonpolyposis colorectal cancer, ulcerative colitis 2) Patients who have undergone surgical resection of the colorectum 3) Patients who use vitamin D (400IU or greater per day) supplement 4) Patients who take non-steroidal anti-inflammatory drugs 3 times or more per week 5) Patients who take vitamin D or calcium supplement as prescribed by a doctor 6) Patients with a history of cancer (excluding those with a history of curative resection of early colorectal cancer or cancer of site other than the colorectum), cerebrovascular events, urinary tract stone, chronic kidney disease, thyroid disease, chronic liver disease (chronic hepatitis, liver cirrhosis), psychiatric disease 7) Patients who have known or anticipated difficulties for study participation throughout study period 8) Patients who are judged by his/her doctor to be unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reccurrence rate of colorectal tumor (adenoma or cancer) on endoscopic examination at 24 to 28 month or earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Occurrence rate of high-risk colorectal adenoma or cancer in terms of size, number, and histology 2) adverse event rate (Outcomes other than colorectal tumor) 1) influenza: diagnosis of influenza, occurrence of influenza-like illness 2) allergy: occurrence of allergic disease and symptoms 3) blood pressure 4) glucose metabolism: fasting gluose, HbA1c, insulin, C-peptide, HOMA-IR 5) lipids: total/HDL/LDL-cholesterol, triglycerides, fatty acid composition 6) inflammation: hs-CRP, IL6, adiponectin, leptin, TNF-alpa, PAI-1, other markers of inflamation 7) bone metabolism: Intact parathyroid hormone (PTH), Osteocalcin, Type I collagen cross-linked N-telopeptides(NTX) 8) depression: CES-D (For extended study: additional two-year observation) 1) 4-year reccurrence rate of colorectal tumor (adenoma or cancer) | — |
Countries
Japan
Contacts
Public ContactTetsuya Mizoue
National Center for Global Health and Medicine, Clinical Research Center Department of Epidemiology and Prevention
Outcome results
None listed