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(SCoViDS): Scottish Vitamin D Intervention Study

Sponsor
University of Edinburgh (Other)
Overall Status
Completed
CT.gov ID
NCT04868227
Collaborator
Cancer Research UK (Other), Medical Research Council (Other)
190
Enrollment
1
Location
1
Arm
27.5
Actual Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: FULTIUM D3 VITAMIN D3
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
SINGLE GROUP INTERVENTION STUDYSINGLE GROUP INTERVENTION STUDY
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Scottish Vitamin D Intervention Study
Actual Study Start Date :
Mar 28, 2014
Actual Primary Completion Date :
Apr 11, 2016
Actual Study Completion Date :
Jul 11, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: INTERVENTION STUDY

TREATED WITH 3200IU FULTIUM VITAMIN D3

Dietary Supplement: FULTIUM D3 VITAMIN D3
VITAMIN D3 SUPPLEMENT

Outcome Measures

Primary Outcome Measures

  1. GENE EXPRESSION [AT BASELINE]

    RECTAL MUCOSA GENE EXPRESSION

  2. GENE EXPRESSION CHANGE [AFTER 6 WEEK'S SUPPLEMENTATION]

    RECTAL MUCOSA GENE EXPRESSION

  3. GENE EXPRESSION CHANGE [AFTER 12 WEEK'S SUPPLEMENTATION]

    RECTAL MUCOSA GENE EXPRESSION

Secondary Outcome Measures

  1. VITAMIN D STATUS [AT BASELINE]

    25-hydroxy-vitamin D (25-OHD) level

  2. VITAMIN D STATUS CHANGE [AFTER 6 WEEK'S SUPPLEMENTATION]

    25-hydroxy-vitamin D (25-OHD) level

  3. VITAMIN D STATUS CHANGE [AFTER 12 WEEK'S SUPPLEMENTATION]

    25-hydroxy-vitamin D (25-OHD) level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  1. 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

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western General Hospital Edinburgh United Kingdom EH42XU

Sponsors and Collaborators

  • University of Edinburgh
  • Cancer Research UK
  • Medical Research Council

Investigators

  • Principal Investigator: Malcolm G Dunlop, MD, MRC HGU University of Ediniburgh

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT04868227
Other Study ID Numbers:
  • 2014/0058
First Posted:
Apr 30, 2021
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Edinburgh
VITAMIN D
Additional relevant MeSH terms:
Colorectal Neoplasms
Vitamin D
Cholecalciferol

Study Results

No Results Posted as of Apr 30, 2021