Vitamin D Supplementation Study

Not Applicable

Completed

• Conditions: Colorectal Cancer; Vitamin D Deficiency
• Interventions: Dietary Supplement: Fultium

• Registration Number: NCT05506696
• Lead Sponsor: University of Edinburgh

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.

Study Timeline

• Study Start: 2012-09-24
• Primary Completion: 2021-03-18
• Study Completion: 2021-03-31
• Status Verified: 2022-07
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-18
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D supplementation	Fultium	3200IU cholecalciferol (Fultium) peri-operatively

Primary Outcome Measures

Name	Time	Method
25OHD level	Peri-operative, up to 4 weeks post-operative	25OHD level measured by LC/MS

Trial Locations

Locations (1)

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom