Trial Outcomes & Findings for Ancillary Study of Methylation Biomarkers in a Randomized Controlled Trial of a Personalized Prevention of Colorectal Cancer (NCT NCT04196803)
NCT ID: NCT04196803
Last Updated: 2024-06-25
Results Overview
Increases in 5-mC methylation at cg16371860 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression. 5-mC methylation changes=value at 12 weeks minus value at baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
12 Weeks
Results posted on
2024-06-25
Participant Flow
Participants, aged 40-85 y, with colorectal polyp or polyp-free individuals with high risk of colorectal cancer and had a calcium intake of ≥700 and \<2000 mg/d, and their calcium-to-magnesium intake ratio was \>2.6 (based on baseline two 24-hour dietary recalls) and have blood samples were recruited from Vanderbilt patient sources from March 11, 2011 to Jan 30, 2016 .
Participant milestones
| Measure |
Magnesium Treatment
Participants were assigned to magnesium glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo
Participants were assigned to placebo group
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
126
|
|
Overall Study
COMPLETED
|
119
|
120
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Magnesium Treatment
Participants were assigned to magnesium glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo
Participants were assigned to placebo group
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Ancillary Study of Methylation Biomarkers in a Randomized Controlled Trial of a Personalized Prevention of Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Magnesium Treatment
n=119 Participants
Participants were assigned to magnesium glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo
n=120 Participants
Participants were assigned to placebo group
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
160 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 7.7 • n=93 Participants
|
61.2 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
60.7 years
STANDARD_DEVIATION 7.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
126 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
236 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=93 Participants
|
120 participants
n=4 Participants
|
239 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Overall analysis and stratified analysis by age (\<65 years, ≥ 65 years)
Increases in 5-mC methylation at cg16371860 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression. 5-mC methylation changes=value at 12 weeks minus value at baseline.
Outcome measures
| Measure |
Magnesium Treatment
n=119 Participants
Participants were assigned to magnesium glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo
n=120 Participants
Participants were assigned to placebo group
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Changes of Cytosine Modification in TMPRSS2 (5-mC at cg16371860) by Magnesium Treatment Versus Placebo
All
|
0.007 units on CpG sites
Standard Deviation 0.024
|
-0.001 units on CpG sites
Standard Deviation 0.025
|
|
Changes of Cytosine Modification in TMPRSS2 (5-mC at cg16371860) by Magnesium Treatment Versus Placebo
Age<65
|
0.012 units on CpG sites
Standard Deviation 0.022
|
-0.002 units on CpG sites
Standard Deviation 0.022
|
|
Changes of Cytosine Modification in TMPRSS2 (5-mC at cg16371860) by Magnesium Treatment Versus Placebo
Age≥65
|
-0.004 units on CpG sites
Standard Deviation 0.025
|
-0.001 units on CpG sites
Standard Deviation 0.031
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Overall analysis and stratified analysis by age (\<65 years, ≥ 65 years)
Decreases in 5-hmC methylation at cg16371860 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression. 5-hmC methylation changes=value at 12 weeks minus value at baseline.
Outcome measures
| Measure |
Magnesium Treatment
n=119 Participants
Participants were assigned to magnesium glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo
n=120 Participants
Participants were assigned to placebo group
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg16371860) by Magnesium Treatment Versus Placebo
All
|
-0.001 units on CpG sites
Standard Deviation 0.002
|
0.000 units on CpG sites
Standard Deviation 0.002
|
|
Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg16371860) by Magnesium Treatment Versus Placebo
Age<65
|
-0.001 units on CpG sites
Standard Deviation 0.002
|
0.000 units on CpG sites
Standard Deviation 0.002
|
|
Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg16371860) by Magnesium Treatment Versus Placebo
Age≥65
|
-0.000 units on CpG sites
Standard Deviation 0.002
|
0.000 units on CpG sites
Standard Deviation 0.002
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Overall analysis and stratified analysis by age (\<65 years, ≥ 65 years)
Increases in 5-mC methylation at cg26337277 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression. 5-mC methylation changes=value at 12 weeks minus value at baseline.
Outcome measures
| Measure |
Magnesium Treatment
n=119 Participants
Participants were assigned to magnesium glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo
n=120 Participants
Participants were assigned to placebo group
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Changes of Cytosine Modification in TMPRSS2 (5-mC at cg26337277) by Magnesium Treatment Versus Placebo
All
|
0.000 units on CpG sites
Standard Deviation 0.001
|
0.000 units on CpG sites
Standard Deviation 0.002
|
|
Changes of Cytosine Modification in TMPRSS2 (5-mC at cg26337277) by Magnesium Treatment Versus Placebo
Age<65
|
-0.000 units on CpG sites
Standard Deviation 0.002
|
-0.000 units on CpG sites
Standard Deviation 0.002
|
|
Changes of Cytosine Modification in TMPRSS2 (5-mC at cg26337277) by Magnesium Treatment Versus Placebo
Age≥65
|
0.000 units on CpG sites
Standard Deviation 0.001
|
0.000 units on CpG sites
Standard Deviation 0.002
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Overall analysis and stratified analysis by age (\<65 years, ≥ 65 years)
Decreases in 5-hmC methylation at cg26337277 (the promoter) indicate a hindered process of transcription initiation and, subsequently, lower levels of TMPRSS2 expression. 5-hmC methylation changes=value at 12 weeks minus value at baseline.
Outcome measures
| Measure |
Magnesium Treatment
n=119 Participants
Participants were assigned to magnesium glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo
n=120 Participants
Participants were assigned to placebo group
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg26337277) by Magnesium Treatment Versus Placebo
All
|
-0.000 units on CpG sites
Standard Deviation 0.001
|
0.000 units on CpG sites
Standard Deviation 0.001
|
|
Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg26337277) by Magnesium Treatment Versus Placebo
Age<65
|
-0.000 units on CpG sites
Standard Deviation 0.001
|
0.000 units on CpG sites
Standard Deviation 0.001
|
|
Changes of Cytosine Modification in TMPRSS2 (5-hmC at cg26337277) by Magnesium Treatment Versus Placebo
Age≥65
|
-0.000 units on CpG sites
Standard Deviation 0.001
|
0.000 units on CpG sites
Standard Deviation 0.001
|
Adverse Events
Magnesium Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Magnesium Treatment
n=124 participants at risk
Participants were assigned to magnesium glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo
n=126 participants at risk
Participants were assigned to placebo group
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.81%
1/124 • Number of events 1 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
1.6%
2/126 • Number of events 2 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
|
Gastrointestinal disorders
Bleeding after the rectal biopsy procedure
|
0.00%
0/124 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
0.79%
1/126 • Number of events 1 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
|
General disorders
Feel sick
|
0.81%
1/124 • Number of events 1 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
0.00%
0/126 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
|
General disorders
Arthritic pain in fingers
|
0.81%
1/124 • Number of events 1 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
0.00%
0/126 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
|
General disorders
Weight gain
|
0.81%
1/124 • Number of events 1 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
0.00%
0/126 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
|
Vascular disorders
Interaction with blood pressure medication
|
0.81%
1/124 • Number of events 1 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
0.00%
0/126 • In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place