Clinical trial · Interventional
Scottish Vitamin D Intervention Study
NCT04868227CI-TRIAL-00085084(SCoViDS)completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| GENE EXPRESSION | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FULTIUM D3 VITAMIN D3 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INTERVENTION STUDY
- description
- TREATED WITH 3200IU FULTIUM VITAMIN D3
- interventionNames
- Dietary Supplement: FULTIUM D3 VITAMIN D3
Primary outcomes (2)
- measure
- Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level
- timeFrame
- AT BASELINE
- description
- RECTAL MUCOSA GENE EXPRESSION (HT12 microarray. No units on gene expression array)
- measure
- GENE EXPRESSION CHANGE
- timeFrame
- AFTER 12 WEEK'S SUPPLEMENTATION
- description
- RECTAL MUCOSA GENE EXPRESSION. We tested supplemented patients (i.e. response to supplementation) for enrichment of the candidate gene-set. Directional gene-set testing was performed in R, using the gene-setTest function in the 'limma' package. We performed participant-level gene-set enrichment testing with a 'response' to supplementation defined as enrichment (P\<0.001) of the candidate gene-set after supplementation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.