Vitamin D Supplementation Study

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Fultium

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH42XU
    • Western General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D supplementation; 3200IU cholecalciferol (Fultium) peri-operatively	Dietary supplement: Fultium; 3200IU Fultium
No Intervention: Control; No treatment. Control arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
25OHD level	25OHD level measured by LC/MS	Peri-operative, up to 4 weeks post-operative

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Principal Investigator: Malcolm Dunlop, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2012
• Primary Completion (Actual): March 18, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: colorectal; vitamin D
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Nutrition Disorders; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Colorectal Neoplasms; Vitamin D Deficiency
• Other Study ID Numbers: 2014/0058.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No