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Vitamin D Supplementation Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05506696
Enrollment
122
Registered
2022-08-18
Start date
2012-09-24
Completion date
2021-03-31
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Vitamin D Deficiency

Keywords

colorectal, vitamin D

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.

Interventions

DIETARY_SUPPLEMENTFultium

3200IU Fultium

Sponsors

University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
25OHD levelPeri-operative, up to 4 weeks post-operative25OHD level measured by LC/MS

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026