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Completed

NCT Number: NCT05506696

Vitamin D Supplementation Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fultium

Dietary Supplement

3200IU Fultium

Primary outcomes

  1. 25OHD level

    Time frame: Peri-operative, up to 4 weeks post-operative

    25OHD level measured by LC/MS

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2022
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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