Scottish Vitamin D Intervention Study ((SCoViDS))

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; GENE EXPRESSION
• Intervention / Treatment: Dietary supplement: FULTIUM D3 VITAMIN D3

Detailed Description

Through National Health Service (NHS) clinical services in colorectal surgery and oncology, patients will be identified and recruited from surgical wards or surgical/oncology out-patient clinics. A sample of participants with and without a new or previous diagnosis of colorectal cancer will be included for comparison.

Participation will consist of two events in the majority of participants. Firstly a in the surgical ward or clinic lasting no longer than 20 minutes in which the research will be discussed and informed consent gained. A blood sample will be taken prior to the conclusion of recruitment and a rectal biopsy taken using a rigid sigmoidoscopy which may or may not be required as part of their routine clinical assessment. Participants will be asked to take pharmaceutical grade vitamin D tablets for 3 months. After 12 weeks of vitamin D supplementation, a final blood sample and rectal biopsy will be taken.

If patients would like to contribute but cannot or would prefer not to take vitamin D, or cannot return for future sampling, a single sampling will be offered. This participant would undergo blood sampling and rectal biopsy as above. After this no further events would occur.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH42XU
    • Western General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. The inability to provide informed consent.
2. Under the age of 16 years.
3. A non-UK resident.

4. 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
   • Anal fissure
   • Severe coagulopathy
   • Anticoagulant therapy
   • Severe thrombocytopenia
   • Severe neutropenia

5. Patients who may be at increased risk from Vitamin D supplementation would not be included in the intervention arm but could still be included in the single sample arm:

   • 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

6. Patients in whom vitamin D levels may be unpredictable

   • Individuals already established on supplementary Vitamin D.
   • Individuals recently returned to the UK from an overseas holiday.
   • Individuals who have recently lived abroad.
   • Patients on anti-epileptic medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTERVENTION STUDY; TREATED WITH 3200IU FULTIUM VITAMIN D3	Dietary supplement: FULTIUM D3 VITAMIN D3; VITAMIN D3 SUPPLEMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VITAMIN D STATUS	Blood vitamin D level (25-hydroxy-vitamin D (25-OHD) level (nmol/l)) using Liquid chromatography tandem mass spectrometry (LC- MS/MS)	AT BASELINE
VITAMIN D STATUS CHANGE	Blood vitamin D level (25-hydroxy-vitamin D (25-OHD) level (nmol/l))	AFTER 12 WEEK'S SUPPLEMENTATION

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: Medical Research Council; Cancer Research UK
• Investigators: Principal Investigator: Malcolm G Dunlop, MD, MRC HGU University of Ediniburgh

Publications and helpful links

Helpful Links

• GEO ID GSE157982.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2014
• Primary Completion (Actual): April 11, 2016
• Study Completion (Actual): July 11, 2016

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: VITAMIN D
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 2014/0058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: AS REQUESTED
• IPD Sharing Access Criteria: Full protocol and Full phenotypic data available from the corresponding author on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No