Scottish Vitamin D Intervention Study ((SCoViDS))

• ClinicalTrials.gov Identifier: NCT04868227
• Recruitment Status: Completed
• First Posted: April 30, 2021
• Last Update Posted: April 30, 2021
• Sponsor: University of Edinburgh
• Collaborators: Cancer Research UK; Medical Research Council
• Information provided by (Responsible Party): University of Edinburgh

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.

Condition or disease	Intervention/treatment	Phase
GENE EXPRESSION; Colorectal Cancer	Dietary Supplement: FULTIUM D3 VITAMIN D3	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 190 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: SINGLE GROUP INTERVENTION STUDY
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Scottish Vitamin D Intervention Study
• Actual Study Start Date: March 28, 2014
• Actual Primary Completion Date: April 11, 2016
• Actual Study Completion Date: July 11, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: INTERVENTION STUDY; TREATED WITH 3200IU FULTIUM VITAMIN D3	Dietary Supplement: FULTIUM D3 VITAMIN D3; VITAMIN D3 SUPPLEMENT

Outcome Measures

Primary Outcome Measures :

1. GENE EXPRESSION [ Time Frame: AT BASELINE ]
   RECTAL MUCOSA GENE EXPRESSION
2. GENE EXPRESSION CHANGE [ Time Frame: AFTER 6 WEEK'S SUPPLEMENTATION ]
   RECTAL MUCOSA GENE EXPRESSION
3. GENE EXPRESSION CHANGE [ Time Frame: AFTER 12 WEEK'S SUPPLEMENTATION ]
   RECTAL MUCOSA GENE EXPRESSION

Secondary Outcome Measures :

1. VITAMIN D STATUS [ Time Frame: AT BASELINE ]
   25-hydroxy-vitamin D (25-OHD) level
2. VITAMIN D STATUS CHANGE [ Time Frame: AFTER 6 WEEK'S SUPPLEMENTATION ]
   25-hydroxy-vitamin D (25-OHD) level
3. VITAMIN D STATUS CHANGE [ Time Frame: AFTER 12 WEEK'S SUPPLEMENTATION ]
   25-hydroxy-vitamin D (25-OHD) level

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United Kingdom

Western General Hospital

Edinburgh, United Kingdom, EH42XU

Sponsors and Collaborators

University of Edinburgh

Cancer Research UK

Medical Research Council

Investigators

• Principal Investigator: Malcolm G Dunlop, MD; MRC HGU University of Ediniburgh

More Information

Additional Information:

GEO ID GSE157982. 

• Responsible Party: University of Edinburgh
• ClinicalTrials.gov Identifier: NCT04868227
• Other Study ID Numbers: 2014/0058
• First Posted: April 30, 2021
• Last Update Posted: April 30, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Time Frame: AS REQUESTED
• Access Criteria: Full protocol and Full phenotypic data available from the corresponding author on reasonable request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Edinburgh:

VITAMIN D

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Vitamin D; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents