Scottish Vitamin D Intervention Study ((SCoViDS))

University of Edinburgh

Status: Completed

Conditions: GENE EXPRESSION; Colorectal Cancer

Treatments: Dietary Supplement: FULTIUM D3 VITAMIN D3

Study type: Interventional

Funder types: Other

Identifiers

NCT04868227

2014/0058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

INTERVENTION STUDY

Experimental group

Description:

TREATED WITH 3200IU FULTIUM VITAMIN D3

Treatment:

Dietary Supplement: FULTIUM D3 VITAMIN D3