Clinical trial NCT04868227: Scottish Vitamin D Intervention Study
Official title: Scottish Vitamin D Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GENE EXPRESSION
Colorectal Cancer
Keywords: VITAMIN D
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: Medical Research Council
First posted: 2021-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SINGLE GROUP INTERVENTION STUDY
Primary purpose: PREVENTION

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level
timeFrame: AT BASELINE
measure: GENE EXPRESSION CHANGE
timeFrame: AFTER 12 WEEK'S SUPPLEMENTATION
Secondary outcomes:
measure: VITAMIN D STATUS
timeFrame: AT BASELINE
measure: VITAMIN D STATUS CHANGE
timeFrame: AFTER 12 WEEK'S SUPPLEMENTATION
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
Study officials:
affiliation: MRC HGU University of Ediniburgh
name: Malcolm G Dunlop, MD
role: PRINCIPAL_INVESTIGATOR
References: