Trial Outcomes & Findings for Precision-Based Magnesium Trial (NCT NCT01105169)
NCT ID: NCT01105169
Last Updated: 2026-02-20
Results Overview
Transient Receptor Potential Melastatin 7 (TRPM7) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. . Changes (posttreatment-baseline) of TRPM7=log(value at 12 weeks) minus log(value at baseline).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2026-02-20
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) were recruited from Vanderbilt Vanderbilt University Medical Center (VUMC), Nashville, Tennessee from 2011 to 2024.
Participant milestones
| Measure |
GG Participants in Magnesium Treatment
Participants with GG genotype were assigned to magnesium glycinate.
Oral administration of magnesium glycinate daily for 12 weeks. The dose is personalized based on the baseline assessment of dietary intakes.
|
GG Participants in Placebo
Participants with GG genotype were assigned to placebo group
Oral administration of identical-appearing placebo daily for 12 weeks.
|
GA/AA Participants in Magnesium Treatment
Participants with GA/AA genotype were assigned to magnesium glycinate.
Oral administration of magnesium glycinate daily for 12 weeks. The dose is personalized based on the baseline assessment of dietary intakes.
|
GA/AA Participants in Placebo
Participants with GA/AA genotype were assigned to placebo group.
Oral administration of identical-appearing placebo daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
78
|
47
|
48
|
|
Overall Study
COMPLETED
|
76
|
75
|
43
|
45
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
4
|
3
|
Reasons for withdrawal
| Measure |
GG Participants in Magnesium Treatment
Participants with GG genotype were assigned to magnesium glycinate.
Oral administration of magnesium glycinate daily for 12 weeks. The dose is personalized based on the baseline assessment of dietary intakes.
|
GG Participants in Placebo
Participants with GG genotype were assigned to placebo group
Oral administration of identical-appearing placebo daily for 12 weeks.
|
GA/AA Participants in Magnesium Treatment
Participants with GA/AA genotype were assigned to magnesium glycinate.
Oral administration of magnesium glycinate daily for 12 weeks. The dose is personalized based on the baseline assessment of dietary intakes.
|
GA/AA Participants in Placebo
Participants with GA/AA genotype were assigned to placebo group.
Oral administration of identical-appearing placebo daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Precision-Based Magnesium Trial
Baseline characteristics by cohort
| Measure |
GG Participants in Magnesium Treatment
n=76 Participants
Participants with GG genotype were assigned to magnesium glycinate.
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=75 Participants
Participants with GG genotype were assigned to placebo group.
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=43 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate.
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
GA/AA Participants in Placebo
n=45 Participants
Participants with GA/AA genotype were assigned to placebo group.
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=687 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=14 Participants
|
52 Participants
n=14 Participants
|
29 Participants
n=29 Participants
|
26 Participants
n=687 Participants
|
160 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=14 Participants
|
23 Participants
n=14 Participants
|
14 Participants
n=29 Participants
|
19 Participants
n=687 Participants
|
79 Participants
n=6 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 8.2 • n=14 Participants
|
61.0 years
STANDARD_DEVIATION 8.5 • n=14 Participants
|
60.0 years
STANDARD_DEVIATION 7.0 • n=29 Participants
|
61.4 years
STANDARD_DEVIATION 7.6 • n=687 Participants
|
60.7 years
STANDARD_DEVIATION 7.9 • n=6 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=14 Participants
|
35 Participants
n=14 Participants
|
23 Participants
n=29 Participants
|
23 Participants
n=687 Participants
|
113 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=14 Participants
|
40 Participants
n=14 Participants
|
20 Participants
n=29 Participants
|
22 Participants
n=687 Participants
|
126 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=687 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=687 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=687 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=687 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=14 Participants
|
74 Participants
n=14 Participants
|
43 Participants
n=29 Participants
|
45 Participants
n=687 Participants
|
236 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=687 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=687 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=14 Participants
|
75 participants
n=14 Participants
|
43 participants
n=29 Participants
|
45 participants
n=687 Participants
|
239 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPopulation: Participants with pre and post intervention samples available
Transient Receptor Potential Melastatin 7 (TRPM7) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. . Changes (posttreatment-baseline) of TRPM7=log(value at 12 weeks) minus log(value at baseline).
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=41 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=70 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=71 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=42 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
TRPM7 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo
|
-0.11 log (arbitrary units)
Interval -0.52 to 0.32
|
0.03 log (arbitrary units)
Interval -0.66 to 1.09
|
0.08 log (arbitrary units)
Interval -0.79 to 0.8
|
-0.09 log (arbitrary units)
Interval -0.8 to 0.37
|
PRIMARY outcome
Timeframe: Baseline to 12 weekPopulation: Participants with pre and post intervention samples available.
Cyclooxygenase (COX2) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. . Changes (posttreatment-baseline) of COX2=log(value at 12 weeks) minus log(value at baseline).
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=39 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=70 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=70 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=41 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
COX2 Expression Level in Colorectal Mucosa by Mg Treatment Compared With Placebo
|
-0.29 log (arbitrary units)
Interval -0.67 to 0.47
|
0.10 log (arbitrary units)
Interval -0.47 to 0.58
|
0.08 log (arbitrary units)
Interval -0.56 to 0.55
|
0.11 log (arbitrary units)
Interval -0.34 to 0.64
|
PRIMARY outcome
Timeframe: Baseline to 12 weekPopulation: Participants with pre and post intervention samples available.
Terminal Deoxynucleotidyl Transferase dUTP Nick End Labeling (TUNEL) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant) and computed as count of apoptotic cells/mm2 of epithelial cell nuclei area (cells/mm²). Changes (posttreatment-baseline) of TUNEL =log(value at 12 weeks) minus log(value at baseline).
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=41 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=73 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=71 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=43 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
TUNEL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
|
-0.09 log(cells/mm^2)
Interval -0.82 to 1.06
|
0.24 log(cells/mm^2)
Interval -0.48 to 1.0
|
0.14 log(cells/mm^2)
Interval -0.7 to 1.03
|
-0.09 log(cells/mm^2)
Interval -0.96 to 0.57
|
PRIMARY outcome
Timeframe: Baseline to 12 weekPopulation: Participants with pre and post intervention samples available.
BCL2-associated X (BAX) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. Changes (posttreatment-baseline) of BAX=log(value at 12 weeks) minus log(value at baseline).
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=41 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=73 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=71 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=43 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
BAX Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
|
-0.19 log (arbitrary units)
Interval -0.63 to 0.53
|
-0.03 log (arbitrary units)
Interval -0.72 to 0.82
|
-0.30 log (arbitrary units)
Interval -0.84 to 0.36
|
-0.18 log (arbitrary units)
Interval -0.86 to 0.82
|
PRIMARY outcome
Timeframe: Baseline to 12 weekPopulation: Participants with pre and post intervention samples available.
Phosphorylated Mixed Lineage Kinase Like (pMLKL) levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant). The staining score was computed as "positive cell percentage x reciprocal staining intensity (RSI)", yielding values from 0 to 255, where higher score denoted stronger staining. Changes (posttreatment-baseline) of pMLKL=log(value at 12 weeks) minus log(value at baseline).
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=41 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=70 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=71 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=42 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
pMLKL Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
|
-0.16 log (arbitrary units)
Interval -0.43 to 0.7
|
0.11 log (arbitrary units)
Interval -0.45 to 0.63
|
0.05 log (arbitrary units)
Interval -0.41 to 0.62
|
0.02 log (arbitrary units)
Interval -0.45 to 0.44
|
PRIMARY outcome
Timeframe: Baseline to 12 weekPopulation: Participants with pre and post intervention samples available.
Ki67 levels were evaluated quantitatively using a computer-based imaging system composed of an Olympus BX40 Microscope and BioQuant NOVA Prime imaging software (BioQuant) and calculated as positive nuclei area / epithelial cell nuclei area \* 100 (%). Changes (posttreatment-baseline) of Ki67=log(value at 12 weeks) minus log(value at baseline).
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=41 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=72 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=70 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=41 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
Ki67 Expression in Colorectal Mucosa by Mg Treatment Compared With Placebo
|
-0.10 log(percentage of positive nuclei area)
Interval -0.48 to 0.07
|
-0.11 log(percentage of positive nuclei area)
Interval -0.53 to 0.47
|
0.11 log(percentage of positive nuclei area)
Interval -0.46 to 0.51
|
-0.03 log(percentage of positive nuclei area)
Interval -0.41 to 0.37
|
SECONDARY outcome
Timeframe: Baseline to 12 weekPopulation: Participants with pre and post intervention samples available.
Changes (posttreatment-baseline) of serum magnesium (measured continuously using 7D70 Magnesium Reagent Kit from Abbot Laboratories (Abbott Park, IL) )
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=45 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=76 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=75 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=43 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
Serum Magnesium by Mg Treatment Compared With Placebo
|
-0.10 mg/dL
Interval -0.2 to 0.0
|
0.00 mg/dL
Interval -0.1 to 0.2
|
0.00 mg/dL
Interval -0.2 to 0.1
|
0.00 mg/dL
Interval -0.1 to 0.2
|
SECONDARY outcome
Timeframe: At week 12Population: 78 participants with samples available.
Post treatment body magnesium status obtained using magnesium tolerance test (MTT) Mg retention rate (%)=\[1-(post-infusion Mg excretion - pre-infusion Mg excretion) / total Mg infused\]\*100.
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=8 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=29 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=30 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=11 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
Post Treatment Body Magnesium Status by Mg Treatment and Placebo
|
42.24 percentage of Mg administered dose
Interval 34.8 to 54.99
|
35.68 percentage of Mg administered dose
Interval 23.79 to 51.98
|
41.58 percentage of Mg administered dose
Interval 17.16 to 59.0
|
60.65 percentage of Mg administered dose
Interval 53.29 to
|
SECONDARY outcome
Timeframe: Baseline to 12 weekPopulation: Assays of CRP only for 150 participants with pre and post intervention samples available.
Changes (posttreatment-baseline) of CRP (measured continuously using turbidimetric immunoassay (Pointe Scientific, Inc, Canton, MI)
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=18 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=61 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=56 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=15 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
Serum C-reactive Protein (CRP) by Mg Treatment Compared With Placebo
|
-0.12 mg/L
Interval -0.83 to 0.38
|
0.04 mg/L
Interval -0.48 to 0.71
|
-0.09 mg/L
Interval -0.88 to 0.57
|
-0.47 mg/L
Interval -1.83 to 0.56
|
SECONDARY outcome
Timeframe: Baseline to 12 weekPopulation: Assays of PGE-M only for 79 participants with pre and post intervention samples available.
Changes (posttreatment-baseline) of PGE-M (measured continuously using a liquid chromatography/tandem mass spectrometric method).
Outcome measures
| Measure |
GA/AA Participants in Placebo
n=15 Participants
Participants with GA/AA genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GG Participants in Magnesium Treatment
n=27 Participants
Participants with GG were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=25 Participants
Participants with GG genotype were assigned to placebo: oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=12 Participants
Participants with GA/AA genotype were assigned to magnesium glycinate: oral administration of magnesium glycinate daily for 12 weeks
|
|---|---|---|---|---|
|
Urine Prostaglandin E2 Metabolite (PGE-M) by Mg Treatment Compared With Placebo
|
-0.25 ng/mg creatinine
Interval -2.36 to 1.06
|
-0.36 ng/mg creatinine
Interval -2.57 to 1.91
|
-0.24 ng/mg creatinine
Interval -2.44 to 1.19
|
0.02 ng/mg creatinine
Interval -0.9 to 3.36
|
Adverse Events
GG Participants in Magnesium Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GG Participants in Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GA/AA Participants in Magnesium Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GA/AA Participants in Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GG Participants in Magnesium Treatment
n=77 participants at risk
Participants with GG genotype were assigned to magnesium glycinate.
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
GG Participants in Placebo
n=78 participants at risk
Participants with GG genotype were assigned to placebo.
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
GA/AA Participants in Magnesium Treatment
n=47 participants at risk
Participants with GA/AA genotype were assigned to magnesium glycinate.
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
GA/AA Participants in Placebo
n=48 participants at risk
Participants with GA/AA genotype were assigned to placebo.
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/77 • 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.
|
1.3%
1/78 • 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.
|
2.1%
1/47 • 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.
|
2.1%
1/48 • 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.
|
|
Gastrointestinal disorders
Bleeding after the rectal biopsy procedure
|
0.00%
0/77 • 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.
|
1.3%
1/78 • 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%
0/47 • 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%
0/48 • 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
Feel sick
|
1.3%
1/77 • 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%
0/78 • 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%
0/47 • 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%
0/48 • 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
Having an adverse effect on his blood pressure medication
|
0.00%
0/77 • 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%
0/78 • 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.
|
2.1%
1/47 • 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%
0/48 • 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, migraine and swelling with arthritic pain in fingers
|
0.00%
0/77 • 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%
0/78 • 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.
|
2.1%
1/47 • 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%
0/48 • 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