GENE EXPRESSION(SCoViDS)NCT04868227
Scottish Vitamin D Intervention Study
A study testing FULTIUM D3 VITAMIN D3 in people with GENE EXPRESSION and Colorectal Cancer, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- GENE EXPRESSION, Colorectal Cancer
- What is being tested?
- FULTIUM D3 VITAMIN D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2014to 11 Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 16 years or over.
- Resident of the United Kingdom
Who cannot join
- 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.
Show all 36Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- GENE EXPRESSION, Colorectal Cancer
- Being tested
- FULTIUM D3 VITAMIN D3
- Keywords
- VITAMIN D
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FULTIUM D3 VITAMIN D3Dietary supplement
VITAMIN D3 SUPPLEMENT
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION STUDY | Experimental | TREATED WITH 3200IU FULTIUM VITAMIN D3 Receives: Dietary Supplement: FULTIUM D3 VITAMIN D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level
RECTAL MUCOSA GENE EXPRESSION (HT12 microarray. No units on gene expression array)
Measured: AT BASELINE
GENE EXPRESSION CHANGE
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.
Measured: AFTER 12 WEEK'S SUPPLEMENTATION
Secondary outcomes (2)
VITAMIN D STATUS
Blood vitamin D level (25-hydroxy-vitamin D (25-OHD) level (nmol/l)) using Liquid chromatography tandem mass spectrometry (LC- MS/MS)
Measured: AT BASELINE
VITAMIN D STATUS CHANGE
Blood vitamin D level (25-hydroxy-vitamin D (25-OHD) level (nmol/l))
Measured: AFTER 12 WEEK'S SUPPLEMENTATION
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start28 Mar 2014
- Primary completion11 Apr 2016
- Study completion11 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GENE EXPRESSIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SINGLE GROUP INTERVENTION STUDY
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Malcolm G Dunlop, MD, Principal investigator, MRC HGU University of Ediniburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868227
- Sponsor's protocol ID
- 2014/0058
- Acronym
- (SCoViDS)
- Status last verified
- Dec 2024
- First submitted
- 25 Apr 2021
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Transcript profiling: Available at https://www.ncbi.nlm.nih.gov/geo/ Gene Expression Omnibus (GEO) identifier (ID) GSE157982. Full phenotypic data available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scottish Vitamin D Intervention Study
- ClinicalTrials.gov ID
- NCT04868227
- Acronym / sponsor ID
- (SCoViDS) / 2014/0058
- Conditions
- GENE EXPRESSION, Colorectal Cancer
- Keywords
- VITAMIN D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Cancer Research UK, Medical Research Council
- Study start
- 28 Mar 2014 (actual)
- Primary completion
- 11 Apr 2016 (actual)
- Study completion
- 11 Jul 2016 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SINGLE GROUP INTERVENTION STUDY
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION STUDY | Experimental | Dietary Supplement: FULTIUM D3 VITAMIN D3TREATED WITH 3200IU FULTIUM VITAMIN D3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 16 years or over.
- Resident of the United Kingdom
Key exclusion criteria (36 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FULTIUM D3 VITAMIN D3VITAMIN D3 SUPPLEMENT | Dietary supplement | INTERVENTION STUDY |
Primary outcome
Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level
Time frame: AT BASELINE
RECTAL MUCOSA GENE EXPRESSION (HT12 microarray. No units on gene expression array)
GENE EXPRESSION CHANGE
Time frame: AFTER 12 WEEK'S SUPPLEMENTATION
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.
2 secondary outcomes
VITAMIN D STATUS
Time frame: AT BASELINE
VITAMIN D STATUS CHANGE
Time frame: AFTER 12 WEEK'S SUPPLEMENTATION
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- GEO ID GSE157982.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Transcript profiling: Available at https://www.ncbi.nlm.nih.gov/geo/ Gene Expression Omnibus (GEO) identifier (ID) GSE157982. Full phenotypic data available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm G Dunlop, MD principal investigator
MRC HGU University of Ediniburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FULTIUM D3 VITAMIN D3 in people with GENE EXPRESSION and Colorectal Cancer, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level (time frame: AT BASELINE). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.