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Scottish Vitamin D Intervention Study ((SCoViDS))

Primary Purpose

GENE EXPRESSION, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
FULTIUM D3 VITAMIN D3
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for GENE EXPRESSION focused on measuring VITAMIN D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Western General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INTERVENTION STUDY

Arm Description

TREATED WITH 3200IU FULTIUM VITAMIN D3

Outcomes

Primary Outcome Measures

GENE EXPRESSION
RECTAL MUCOSA GENE EXPRESSION
GENE EXPRESSION CHANGE
RECTAL MUCOSA GENE EXPRESSION
GENE EXPRESSION CHANGE
RECTAL MUCOSA GENE EXPRESSION

Secondary Outcome Measures

VITAMIN D STATUS
25-hydroxy-vitamin D (25-OHD) level
VITAMIN D STATUS CHANGE
25-hydroxy-vitamin D (25-OHD) level
VITAMIN D STATUS CHANGE
25-hydroxy-vitamin D (25-OHD) level

Full Information

First Posted
April 25, 2021
Last Updated
April 27, 2021
Sponsor
University of Edinburgh
Collaborators
Cancer Research UK, Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT04868227
Brief Title
Scottish Vitamin D Intervention Study
Acronym
(SCoViDS)
Official Title
Scottish Vitamin D Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 28, 2014 (Actual)
Primary Completion Date
April 11, 2016 (Actual)
Study Completion Date
July 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
Cancer Research UK, Medical Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GENE EXPRESSION, Colorectal Cancer
Keywords
VITAMIN D

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
SINGLE GROUP INTERVENTION STUDY
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INTERVENTION STUDY
Arm Type
Experimental
Arm Description
TREATED WITH 3200IU FULTIUM VITAMIN D3
Intervention Type
Dietary Supplement
Intervention Name(s)
FULTIUM D3 VITAMIN D3
Intervention Description
VITAMIN D3 SUPPLEMENT
Primary Outcome Measure Information:
Title
GENE EXPRESSION
Description
RECTAL MUCOSA GENE EXPRESSION
Time Frame
AT BASELINE
Title
GENE EXPRESSION CHANGE
Description
RECTAL MUCOSA GENE EXPRESSION
Time Frame
AFTER 6 WEEK'S SUPPLEMENTATION
Title
GENE EXPRESSION CHANGE
Description
RECTAL MUCOSA GENE EXPRESSION
Time Frame
AFTER 12 WEEK'S SUPPLEMENTATION
Secondary Outcome Measure Information:
Title
VITAMIN D STATUS
Description
25-hydroxy-vitamin D (25-OHD) level
Time Frame
AT BASELINE
Title
VITAMIN D STATUS CHANGE
Description
25-hydroxy-vitamin D (25-OHD) level
Time Frame
AFTER 6 WEEK'S SUPPLEMENTATION
Title
VITAMIN D STATUS CHANGE
Description
25-hydroxy-vitamin D (25-OHD) level
Time Frame
AFTER 12 WEEK'S SUPPLEMENTATION

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 16 years or over. Resident of the United Kingdom Exclusion Criteria: 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 Anal fissure Severe coagulopathy Anticoagulant therapy Severe thrombocytopenia Severe neutropenia 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm G Dunlop, MD
Organizational Affiliation
MRC HGU University of Ediniburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH42XU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.ncbi.nlm.nih.gov/geo/
Description
GEO ID GSE157982.

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Scottish Vitamin D Intervention Study

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