Clinical trial · Interventional
Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer
Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer
NCT02603757CI-TRIAL-00047450completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study to test whether there is an association between baseline Vitamin D levels, Vitamin D supplementation and survival in patients with stage III colon and stage II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled. Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly) Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D levels will be checked throughout supplementation then followed for 5 years with occasional Vitamin D testing and surveying in order to collect information on recurrence and survival outcomes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- Standard-dose of 2,000 IU Vitamin D3, daily
- interventionNames
- Dietary Supplement: cholecalciferol
- type
- EXPERIMENTAL
- label
- Group B
- description
- Higher-dose of 50,000 IU of Vitamin D3, weekly
- interventionNames
- Dietary Supplement: cholecalciferol
Primary outcomes (1)
- measure
- Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years of age * Willing to stop herbal medications as directed by physician * Willing to stop current supplemental Vitamin D (Multivitamin with Vitamin D component is acceptable) * Willing to travel to Legacy Health/OHSU facility if necessary * Agree to attend study visits outside of standard of care visits, if necessary * Diagnosed with stage III colon or stage II/III rectal cancer that will receive neoadjuvant or adjuvant chemotherapy but have not yet started * Baseline serum Vitamin D level below 52 ng/ml Exclusion Criteria: * ≤ 18 years of age * Colon cancer stages I-II and IV or Rectal cancer stage I or IV * Patients who do not undergo chemotherapy * Patients with prior chemotherapy for this cancer * No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease-free for \> 3 years * Unable to comply with protocol * Unable to provide written informed consent * Unwilling or unable to stop oral supplemental Vitamin D * Patients taking high-dose Vitamin D supplementation (50,000 IU weekly) prior to enrollment * Patients with Vitamin D levels above 52 ng/ml at baseline testing * Patients with hypercalcemia and/or any condition resulting in malabsorption * Investigator does not believe study participation, for any reason, is in the best interest of the patient
References
Publications (10)
- BACKGROUNDFiscella K, Winters P, Tancredi D, Hendren S, Franks P. Racial disparity in death from colorectal cancer: does vitamin D deficiency contribute? Cancer. 2011 Mar 1;117(5):1061-9. doi: 10.1002/cncr.25647. Epub 2010 Oct 13. PMID 20945439
- BACKGROUNDZgaga L, Theodoratou E, Farrington SM, Din FV, Ooi LY, Glodzik D, Johnston S, Tenesa A, Campbell H, Dunlop MG. Plasma vitamin D concentration influences survival outcome after a diagnosis of colorectal cancer. J Clin Oncol. 2014 Aug 10;32(23):2430-9. doi: 10.1200/JCO.2013.54.5947. Epub 2014 Jul 7. PMID 25002714
- BACKGROUNDNg K, Sargent DJ, Goldberg RM, Meyerhardt JA, Green EM, Pitot HC, Hollis BW, Pollak MN, Fuchs CS. Vitamin D status in patients with stage IV colorectal cancer: findings from Intergroup trial N9741. J Clin Oncol. 2011 Apr 20;29(12):1599-606. doi: 10.1200/JCO.2010.31.7255. Epub 2011 Mar 21. PMID 21422438
- BACKGROUNDBrunner RL, Wactawski-Wende J, Caan BJ, Cochrane BB, Chlebowski RT, Gass ML, Jacobs ET, LaCroix AZ, Lane D, Larson J, Margolis KL, Millen AE, Sarto GE, Vitolins MZ, Wallace RB. The effect of calcium plus vitamin D on risk for invasive cancer: results of the Women's Health Initiative (WHI) calcium plus vitamin D randomized clinical trial. Nutr Cancer. 2011;63(6):827-41. doi: 10.1080/01635581.2011.594208. Epub 2011 Jul 20. PMID 21774589
- BACKGROUNDFakih MG, Andrews C, McMahon J, Muindi JR. A prospective clinical trial of cholecalciferol 2000 IU/day in colorectal cancer patients: evidence of a chemotherapy-response interaction. Anticancer Res. 2012 Apr;32(4):1333-8. PMID 22493367
- BACKGROUNDFedirko V, Bostick RM, Flanders WD, Long Q, Shaukat A, Rutherford RE, Daniel CR, Cohen V, Dash C. Effects of vitamin D and calcium supplementation on markers of apoptosis in normal colon mucosa: a randomized, double-blind, placebo-controlled clinical trial. Cancer Prev Res (Phila). 2009 Mar;2(3):213-23. doi: 10.1158/1940-6207.CAPR-08-0157. Epub 2009 Mar 3.