Scottish Vitamin D Intervention Study

NCT ID: NCT04868227

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-28
• Study Completion Date: 2016-07-11

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.

Conditions

GENE EXPRESSION; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

INTERVENTION STUDY

TREATED WITH 3200IU FULTIUM VITAMIN D3

Group Type: EXPERIMENTAL

FULTIUM D3 VITAMIN D3

Intervention Type: DIETARY_SUPPLEMENT

VITAMIN D3 SUPPLEMENT

Interventions

FULTIUM D3 VITAMIN D3

VITAMIN D3 SUPPLEMENT

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cancer Research UK

OTHER

Sponsor Role: collaborator

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm G Dunlop, MD

Role: PRINCIPAL_INVESTIGATOR

MRC HGU University of Ediniburgh

Locations

Western General Hospital

Edinburgh, , United Kingdom

Countries

United Kingdom

Related Links

http://www.ncbi.nlm.nih.gov/geo/

GEO ID GSE157982.

Other Identifiers

2014/0058

Identifier Type: -

Identifier Source: org_study_id