N/A
Completed N=50
Scottish Vitamin D Intervention Study
GENE EXPRESSION · Colorectal Cancer
Source: ClinicalTrials.gov NCT04868227 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level — 629 significant probes (P<0.01)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level |
629 | — |
| PRIMARY GENE EXPRESSION CHANGE |
9 | — |
| SECONDARY VITAMIN D STATUS |
40 | — |
| SECONDARY VITAMIN D STATUS CHANGE |
35.85; 89 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04868227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.