Status:
COMPLETED
Scottish Vitamin D Intervention Study
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
Cancer Research UK
Medical Research Council
Conditions:
GENE EXPRESSION
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 demonstr...
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 sa...
Eligibility Criteria
Inclusion
- Aged 16 years or over.
- Resident of the United Kingdom
Exclusion
- 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
Key Trial Info
Start Date :
March 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04868227
Start Date
March 28 2014
End Date
July 11 2016
Last Update
January 24 2025
Active Locations (1)
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1
Western General Hospital
Edinburgh, United Kingdom, EH42XU