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| Name | Class |
|---|---|
| Cancer Research UK | OTHER |
| Medical Research Council | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTERVENTION STUDY | Experimental | TREATED WITH 3200IU FULTIUM VITAMIN D3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FULTIUM D3 VITAMIN D3 | Dietary Supplement | VITAMIN D3 SUPPLEMENT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level | RECTAL MUCOSA GENE EXPRESSION (HT12 microarray. No units on gene expression array) | 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. | AFTER 12 WEEK'S SUPPLEMENTATION |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | AT BASELINE |
| VITAMIN D STATUS CHANGE | Blood vitamin D level (25-hydroxy-vitamin D (25-OHD) level (nmol/l)) |
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Inclusion Criteria:
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:
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:
Patients in whom vitamin D levels may be unpredictable
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| Name | Affiliation | Role |
|---|---|---|
| Malcolm G Dunlop, MD | MRC HGU University of Ediniburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western General Hospital | Edinburgh | EH42XU | United Kingdom |
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| Label | URL |
|---|---|
| GEO ID GSE157982. | View source |
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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.
AS REQUESTED
Full protocol and Full phenotypic data available from the corresponding author on reasonable request.
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Analyses were intended to be conducted irrespective of previous diagnosis status. i.e. Results are not compared between those with/ without previous history of colorectal cancer.
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| ID | Title | Description |
|---|---|---|
| FG000 | INTERVENTION STUDY (Single Arm Study) | TREATED WITH 3200IU FULTIUM VITAMIN D3 FULTIUM D3 VITAMIN D3: VITAMIN D3 SUPPLEMENT Analyses were intended to be conducted irrespective of previous diagnosis status. i.e. Results are not compared between those with/ without previous history of colorectal cancer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Recruited patients were those both with and without previous history of cancer. However, analyses were intended to be conducted irrespective of previous diagnosis status. i.e. Results are not compared between those with/ without previous history of colorectal cancer.
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| ID | Title | Description |
|---|---|---|
| BG000 | INTERVENTION STUDY | TREATED WITH 3200IU FULTIUM VITAMIN D3 FULTIUM D3 VITAMIN D3: VITAMIN D3 SUPPLEMENT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level | RECTAL MUCOSA GENE EXPRESSION (HT12 microarray. No units on gene expression array) | Recruited patients were those both with and without previous history of cancer. However, analyses were intended to be conducted irrespective of previous diagnosis status. i.e. Results are not compared between those with/ without previous history of colorectal cancer. | Posted | Number | significant probes (P<0.01) | AT BASELINE | Gene expression HT12 microarray. | Gene expression HT12 microarray. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INTERVENTION STUDY | TREATED WITH 3200IU FULTIUM VITAMIN D3. THERE ARE NO INDIVIDUAL ARMS TO REPORT. FULTIUM D3 VITAMIN D3: VITAMIN D3 SUPPLEMENT Participants were followed up for adverse events for the duration of the study (i.e. during vitamin D treatment) but not beyond. |
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This intervention study is larger than many published studies of gene expression and vitamin D supplementation, yet may still have limited power to achieve individual gene significance. Unmeasured variation in environmental exposures (e.g. diet or UVB exposure) may have influenced responses,
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Malcolm Dunlop | University of Edinburgh | +44 (0) 131 651 8602 | malcolm.dunlop@ed.ac.uk |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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SINGLE GROUP INTERVENTION STUDY
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| AFTER 12 WEEK'S SUPPLEMENTATION |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Gene expression HT12 microarray. |
|
|
| Primary | 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. | Recruited patients were those both with and without previous history of cancer. However, analyses were intended to be conducted irrespective of previous diagnosis status. i.e. Results are not compared between those with/ without previous history of colorectal cancer. | Posted | Count of Participants | Participants | AFTER 12 WEEK'S SUPPLEMENTATION |
|
|
|
| Secondary | 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) | Fifty subjects were administered 3200IU/day oral vitamin D3 and matched blood/mucosa resampled after 12 weeks'. Analyses were intended to be conducted irrespective of previous diagnosis status. i.e. Results are not compared between those with/ without previous history of colorectal cancer. | Posted | Median | Inter-Quartile Range | nmol/l | AT BASELINE | Plasma | Plasma |
|
|
|
| Secondary | VITAMIN D STATUS CHANGE | Blood vitamin D level (25-hydroxy-vitamin D (25-OHD) level (nmol/l)) | Recruited patients were those both with and without previous history of cancer. However, analyses were intended to be conducted irrespective of previous diagnosis status. i.e. Results are not compared between those with/ without previous history of colorectal cancer. | Posted | Median | Inter-Quartile Range | nmol/l | AFTER 12 WEEK'S SUPPLEMENTATION |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |