Immunomodulatory Effect of Vitamin D in Colon Cancer Patients: a Randomized Clinical Trial
- Conditions
- Colon cancer stage 1 and 2Male or Female,aged 30ᇟ yearsBeing at least 1 month after surgery No previous chemotherapy or radiotherapyColon cancerInflammatory markersImmune markersVitamin D31ᅉ(OH)2D3
- Registration Number
- TCTR20171106001
- Lead Sponsor
- Chulabhorn International College of Medicine, Thammasat University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 80
The participants have to meet the criteria as follow:
(1)Colon cancer inpatients or outpatients stage I and II receiving treatment and care at the King Chulalongkorn Memorial Hospital and the Police General Hospital, upon signed informed consent
(2)Male or Female, aged 30-75 years
(3)Serum creatinine < 2.0 mg/dl
(4)Total bilirubin < 2 mg/dl
(5)Alanine aminotransferase (ALT) and Aspartate transaminase
(AST) <35 IU/L
(6)Albumin > 3.5 mg/dl
(7)WBC count > 5,000 cells/cu.mm
(8) BMI 18.5-29.9 kg/m2
(9)Being at least 1 month after surgery
(10) No previous chemotherapy or radiotherapy
(11) Having Self-care ability or caregiver
The participants have not to meet the criteria as follow:
(1)Regularly used of vitamin D-containing supplements > 800 IU/day, unless they discontinued vitamin D3 supplementation 2 months or more prior to enrollment
(2)History of hypercalcemia or history of genitourinary stones
(3)Serum calcium > 10.5 mg/dL
(4)Use of medication interfering with vitamin D metabolism
(5) Certain diseases i.e. HIV/AIDS, Diabetes mellitus, Thyroid, Renal and Liver disease
(6)Pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunological markers 3 months Immunological and biochemical tests
- Secondary Outcome Measures
Name Time Method vitamin D status 3 months biochemical test