Vitamin D Supplementation Study

Colorectal Cancer Clinical Trial

Official title:

A Feasibility Study of Perioperative Vitamin D Supplementation in Patients Undergoing Colorectal Cancer Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05506696
• Other study ID #: 2014/0058.1
• Status: Completed
• Phase: N/A
• Start date: September 24, 2012
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2022
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with colorectal cancer will be recruited to undergo vitamin D supplementation in the peri-operative period. Vitamin D levels (25OHD) will be measured to assess response to supplementation.

Description:

Patients with a new diagnosis of colorectal cancer will be recruited from colorectal outpatient clinics after confirmation of eligibility. Potential participants will be identified by their healthcare team comprising of clinical nurse specialist or surgeon and co-enrolment with portfolio studies including ALLEGRO and Prepare-ABC will be permitted. Patients undergoing neo-adjuvant therapy, already established on supplementary Vitamin D or with contra-indications to vitamin D supplementation will be excluded. After informed consent participants will undergo blood sampling at baseline (for 25OHD level and DNA) and given 3200IU cholecalciferol (Fultium) per day to take until the time of surgery (median time from pre-operative clinic 4 weeks). Further blood sampling will be performed on the day of surgery, in the early post-operative period (1-2 days, 3-5 days, 6-9 days) and at the first post-operative clinic appointment. Where possible surplus serum from clinically indicated blood tests will be collected to assay 25OHD and reduce need to additional venesection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 31, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion criteria -

• All participants will be aged 16 years or over.
• Participants must be resident in the United Kingdom.
• Undergoing bowel cancer surgery Exclusion criteria
• Patients who may be at increased risk from Vitamin D supplementation including:
• Kidney disease
• High levels of calcium in the blood
• Atherosclerosis
• Sarcoidosis
• Histoplasmosis
• Over-active parathyroid gland (hyperparathyroidism)
• Lymphoma
• Currently taking thiazide diuretics, digoxin or other cardiac glycosides
• Known allergy to nuts (as peanut oil contained within vitamin D preparations)
• Female subjects of child bearing age who are not taking effective contraception during the period of the trial

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Fultium
3200IU Fultium

Locations

Country	Name	City	State
United Kingdom	Western General Hospital	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25OHD level	25OHD level measured by LC/MS	Peri-operative, up to 4 weeks post-operative