Scottish Vitamin D Intervention Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Scottish Vitamin D Intervention Study

Conditions
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GENE EXPRESSION, Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: FULTIUM D3 VITAMIN D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: SINGLE GROUP INTERVENTION STUDY
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTERVENTION STUDY<br>TREATED WITH 3200IU FULTIUM VITAMIN D3 | Dietary Supplement: FULTIUM D3 VITAMIN D3<br>* VITAMIN D3 SUPPLEMENT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GENE EXPRESSION | RECTAL MUCOSA GENE EXPRESSION | AT BASELINE | 
| GENE EXPRESSION CHANGE | RECTAL MUCOSA GENE EXPRESSION | AFTER 6 WEEK'S SUPPLEMENTATION | 
| GENE EXPRESSION CHANGE | RECTAL MUCOSA GENE EXPRESSION | AFTER 12 WEEK'S SUPPLEMENTATION | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VITAMIN D STATUS | 25-hydroxy-vitamin D (25-OHD) level | AT BASELINE | 
| VITAMIN D STATUS CHANGE | 25-hydroxy-vitamin D (25-OHD) level | AFTER 6 WEEK'S SUPPLEMENTATION | 
| VITAMIN D STATUS CHANGE | 25-hydroxy-vitamin D (25-OHD) level | AFTER 12 WEEK'S SUPPLEMENTATION | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VITAMIN D