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Immunomodulatory Effect of Vitamin D in Colon Cancer Patients: a Randomized Clinical Trial

Immunomodulatory Effect of Vitamin D in Colon Cancer Patients: a Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20171106001
Enrollment
80
Registered
2017-11-06
Start date
2017-11-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer stage 1 and 2 Male or Female&#44

Interventions

Randomized block design by blocking on sex with two arms (vitamin D3 VS non&#45
vitamin D3 supplementations) will be used among 80 patients who meet inclusion and exclusion criteria. Patients in intervention group (40 patients) will receive daily 8&#44
000 IU of vitamin D3 supplementation for 3 months. Then&#44
the immunological response and vitamin D status will be observed.,Patients in conventional group (40 patients) will not receive daily 8&#44
000 IU of vitamin D3 supplementation for 3 months. They just receive standard treatment care as a conventional therapy. Then&#44
the immunological response and vitamin D status will be observed.
Experimental Dietary Supplement,No Intervention No treatment
Vitamin D receiver group,Conventional group

Sponsors

Chulabhorn International College of Medicine, Thammasat University
Lead Sponsor
Chulalongkorn Memorial Hospital
Collaborator

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Immunological markers 3 months Immunological and biochemical tests

Secondary

MeasureTime frame
vitamin D status 3 months biochemical test

Countries

Thailand

Contacts

Public ContactPanita Chaturawit

Nutrition and Dietetics Center, Theptarin Hospital

pchaturawit@gmail.com062-953-2456

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026