NCT04868227

Brief Summary

AIMS To identify the underlying mechanism by which Vitamin D reduces colorectal cancer risk. OBJECTIVES To demonstrate the effects of vitamin D supplementation on serum vitamin D levels. To demonstrate dynamic changes in gene expression in response to vitamin D. To demonstrate the mechanism underlying the gene-environment interaction of vitamin D, susceptibility genetic variants (risk genes) and colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

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

March 28, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2016

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

January 24, 2025

Completed
Last Updated

January 24, 2025

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

April 25, 2021

Results QC Date

July 26, 2022

Last Update Submit

December 10, 2024

Conditions

GENE EXPRESSIONColorectal Cancer

Keywords

VITAMIN D

Outcome Measures

Primary Outcomes (2)

  • Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level

    RECTAL MUCOSA GENE EXPRESSION (HT12 microarray. No units on gene expression array)

    AT BASELINE

  • GENE EXPRESSION CHANGE

    RECTAL MUCOSA GENE EXPRESSION. We tested supplemented patients (i.e. response to supplementation) for enrichment of the candidate gene-set. Directional gene-set testing was performed in R, using the gene-setTest function in the 'limma' package. We performed participant-level gene-set enrichment testing with a 'response' to supplementation defined as enrichment (P\<0.001) of the candidate gene-set after supplementation.

    AFTER 12 WEEK'S SUPPLEMENTATION

Secondary Outcomes (2)

  • VITAMIN D STATUS

    AT BASELINE

  • VITAMIN D STATUS CHANGE

    AFTER 12 WEEK'S SUPPLEMENTATION

Study Arms (1)

INTERVENTION STUDY

EXPERIMENTAL

TREATED WITH 3200IU FULTIUM VITAMIN D3

Dietary Supplement: FULTIUM D3 VITAMIN D3

Interventions

FULTIUM D3 VITAMIN D3DIETARY_SUPPLEMENT

VITAMIN D3 SUPPLEMENT

INTERVENTION STUDY

Eligibility Criteria

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

You may qualify if:

  • Aged 16 years or over.
  • Resident of the United Kingdom

You may not qualify if:

  • The inability to provide informed consent.
  • Under the age of 16 years.
  • A non-UK resident.
  • Patients who may be at increased risk from rigid sigmoidoscopy:
  • Individuals who are taking anti-coagulation medication.
  • Individuals with platelet disease or other bleeding issues.
  • Individuals with a history of a significant rectal bleed.
  • Suspected or known bowel perforation
  • Anal stenosis
  • Acute peritonitis
  • Colonic necrosis
  • Toxic megacolon
  • Acute severe diverticulitis
  • Diverticular abscess
  • Recent colonic surgery
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western General Hospital

Edinburgh, EH42XU, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Limitations and Caveats

This intervention study is larger than many published studies of gene expression and vitamin D supplementation, yet may still have limited power to achieve individual gene significance. Unmeasured variation in environmental exposures (e.g. diet or UVB exposure) may have influenced responses,

Results Point of Contact

Title
Professor Malcolm Dunlop
Organization
University of Edinburgh
malcolm.dunlop@ed.ac.uk
+44 (0) 131 651 8602

Study Officials

  • Malcolm G Dunlop, MD

    MRC HGU University of Ediniburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: SINGLE GROUP INTERVENTION STUDY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2021

First Posted

April 30, 2021

Study Start

March 28, 2014

Primary Completion

April 11, 2016

Study Completion

July 11, 2016

Last Updated

January 24, 2025

Results First Posted

January 24, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Transcript profiling: Available at https://www.ncbi.nlm.nih.gov/geo/ Gene Expression Omnibus (GEO) identifier (ID) GSE157982. Full phenotypic data available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
AS REQUESTED
Access Criteria
Full protocol and Full phenotypic data available from the corresponding author on reasonable request.

Locations

GB(1)