NCT05506696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2012

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2022

Enrollment Period

8.5 years

First QC Date

August 17, 2022

Last Update Submit

August 2, 2023

Conditions

Colorectal CancerVitamin D Deficiency

Keywords

colorectalvitamin D

Outcome Measures

Primary Outcomes (1)

  • 25OHD level

    25OHD level measured by LC/MS

    Peri-operative, up to 4 weeks post-operative

Study Arms (2)

Vitamin D supplementation

EXPERIMENTAL

3200IU cholecalciferol (Fultium) peri-operatively

Dietary Supplement: Fultium

Control

NO INTERVENTION

No treatment. Control arm.

Interventions

FultiumDIETARY_SUPPLEMENT

3200IU Fultium

Vitamin D supplementation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants will be aged 16 years or over.
  • Participants must be resident in the United Kingdom.
  • Undergoing bowel cancer surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western General Hospital

Edinburgh, EH42XU, United Kingdom

Location

MeSH Terms

Conditions

Colorectal NeoplasmsVitamin D Deficiency

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Malcolm Dunlop

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 18, 2022

Study Start

September 24, 2012

Primary Completion

March 18, 2021

Study Completion

March 31, 2021

Last Updated

August 3, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)