Trial Outcomes & Findings for Scottish Vitamin D Intervention Study (NCT NCT04868227)

Results Overview

RECTAL MUCOSA GENE EXPRESSION (HT12 microarray. No units on gene expression array)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

AT BASELINE

Results posted on

2025-01-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INTERVENTION STUDY n=50 Participants TREATED WITH 3200IU FULTIUM VITAMIN D3 FULTIUM D3 VITAMIN D3: VITAMIN D3 SUPPLEMENT
Age, Continuous	66 years n=50 Participants
Sex: Female, Male Female	24 Participants n=50 Participants
Sex: Female, Male Male	26 Participants n=50 Participants

PRIMARY outcome

Timeframe: AT BASELINE

Population: 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.

RECTAL MUCOSA GENE EXPRESSION (HT12 microarray. No units on gene expression array)

Outcome measures

Outcome measures
Measure	INTERVENTION STUDY n=47231 Gene expression HT12 microarray. TREATED WITH 3200IU FULTIUM VITAMIN D3 FULTIUM D3 VITAMIN D3: VITAMIN D3 SUPPLEMENT
Number of Genes Significantly Associated With 25OHD Blood Vitamin D Level	629 significant probes (P<0.01)

PRIMARY outcome

Timeframe: AFTER 12 WEEK'S SUPPLEMENTATION

Population: 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.

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.

Outcome measures

Outcome measures
Measure	INTERVENTION STUDY n=48 Participants TREATED WITH 3200IU FULTIUM VITAMIN D3 FULTIUM D3 VITAMIN D3: VITAMIN D3 SUPPLEMENT
GENE EXPRESSION CHANGE	9 Participants

SECONDARY outcome

Timeframe: AT BASELINE

Population: 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.

Blood vitamin D level (25-hydroxy-vitamin D (25-OHD) level (nmol/l)) using Liquid chromatography tandem mass spectrometry (LC- MS/MS)

Outcome measures

Outcome measures
Measure	INTERVENTION STUDY n=98 Plasma TREATED WITH 3200IU FULTIUM VITAMIN D3 FULTIUM D3 VITAMIN D3: VITAMIN D3 SUPPLEMENT
VITAMIN D STATUS	40 nmol/l Interval 22.5 to 58.5

SECONDARY outcome

Timeframe: AFTER 12 WEEK'S SUPPLEMENTATION

Population: 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.

Blood vitamin D level (25-hydroxy-vitamin D (25-OHD) level (nmol/l))

Outcome measures

Outcome measures
Measure	INTERVENTION STUDY n=50 Participants TREATED WITH 3200IU FULTIUM VITAMIN D3 FULTIUM D3 VITAMIN D3: VITAMIN D3 SUPPLEMENT
VITAMIN D STATUS CHANGE Vitamin D Level at Baseline	35.85 nmol/l Interval 23.14 to 54.41
VITAMIN D STATUS CHANGE Vitamin D Level at 12 weeks	89 nmol/l Interval 72.25 to 105.75

Adverse Events

INTERVENTION STUDY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Malcolm Dunlop

University of Edinburgh

Phone: +44 (0) 131 651 8602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place