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Vitamin D Supplementation Study

Primary Purpose

Colorectal Cancer, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fultium
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer focused on measuring colorectal, vitamin D

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vitamin D supplementation

Control

Arm Description

3200IU cholecalciferol (Fultium) peri-operatively

No treatment. Control arm.

Outcomes

Primary Outcome Measures

25OHD level
25OHD level measured by LC/MS

Secondary Outcome Measures

Full Information

First Posted
August 17, 2022
Last Updated
August 2, 2023
Sponsor
University of Edinburgh
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1. Study Identification

Unique Protocol Identification Number
NCT05506696
Brief Title
Vitamin D Supplementation Study
Official Title
A Feasibility Study of Perioperative Vitamin D Supplementation in Patients Undergoing Colorectal Cancer Resection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 24, 2012 (Actual)
Primary Completion Date
March 18, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Vitamin D Deficiency
Keywords
colorectal, vitamin D

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D supplementation
Arm Type
Experimental
Arm Description
3200IU cholecalciferol (Fultium) peri-operatively
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment. Control arm.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fultium
Intervention Description
3200IU Fultium
Primary Outcome Measure Information:
Title
25OHD level
Description
25OHD level measured by LC/MS
Time Frame
Peri-operative, up to 4 weeks post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm Dunlop
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH42XU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Vitamin D Supplementation Study

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