Vitamin D Supplementation Study

Sponsor

University of Edinburgh (Other)

Overall Status

Completed

CT.gov ID

NCT05506696

Collaborator

(none)

122

Enrollment

Location

Arms

102.2

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Vitamin D Deficiency	Dietary Supplement: Fultium	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 24, 2012

Actual Primary Completion Date :

Mar 18, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Vitamin D supplementation

3200IU cholecalciferol (Fultium) peri-operatively

Dietary Supplement: Fultium

3200IU Fultium

No Intervention: Control

No treatment. Control arm.

Outcome Measures

Primary Outcome Measures

25OHD level [Peri-operative, up to 4 weeks post-operative]
25OHD level measured by LC/MS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western General Hospital	Edinburgh		United Kingdom	EH42XU

Sponsors and Collaborators

University of Edinburgh

Investigators

Principal Investigator: Malcolm Dunlop, University of Edinburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Edinburgh

ClinicalTrials.gov Identifier:

NCT05506696

Other Study ID Numbers:

2014/0058.1

First Posted:

Aug 18, 2022

Last Update Posted:

Aug 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Edinburgh

colorectal

vitamin D

Additional relevant MeSH terms:

Colorectal Neoplasms

Vitamin D Deficiency

Study Results

No Results Posted as of Aug 19, 2022