Trial Outcomes & Findings for Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation (NCT NCT04229992)

Last Updated: 2025-01-28

Results Overview

changes=value at 12 weeks minus value at baseline. Difference between post-treatment and baseline, means increase or reduced the abundance of genera Prevotella in the test samples (rectal mucosa or rectal swab or stool).

Recruitment status

COMPLETED

Study phase

Target enrollment

250 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-01-28

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

Participant milestones
Measure	GG Genotype and Magnesium Treatment Participants who have the GG genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GG Genotype and Placebo Participants who have the GG genotype were assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks	GA/AA Genotype and Magnesium Treatment Participants who have the GA/AA genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GA/AA Genotype and Placebo Participants who have the GA/AA genotype were assigned to placebo group Placebo: 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

Reasons for withdrawal
Measure	GG Genotype and Magnesium Treatment Participants who have the GG genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GG Genotype and Placebo Participants who have the GG genotype were assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks	GA/AA Genotype and Magnesium Treatment Participants who have the GA/AA genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GA/AA Genotype and Placebo Participants who have the GA/AA genotype were assigned to placebo group Placebo: 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

Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GG Genotype and Magnesium Treatment n=76 Participants Participants who have the GG genotype will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GG Genotype and Placebo n=75 Participants Participants who have the GG genotype will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks	GA/AA Genotype and Magnesium Treatment n=43 Participants Participants who have the GA/AA genotype will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GA/AA Genotype and Placebo n=45 Participants Participants who have the GA/AA genotype will be 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=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=99 Participants	52 Participants n=107 Participants	29 Participants n=206 Participants	26 Participants n=7 Participants	160 Participants n=31 Participants
Age, Categorical >=65 years	23 Participants n=99 Participants	23 Participants n=107 Participants	14 Participants n=206 Participants	19 Participants n=7 Participants	79 Participants n=31 Participants
Age, Continuous	60.2 years STANDARD_DEVIATION 8.2 • n=99 Participants	60.0 years STANDARD_DEVIATION 8.5 • n=107 Participants	60.0 years STANDARD_DEVIATION 7.0 • n=206 Participants	61.4 years STANDARD_DEVIATION 7.6 • n=7 Participants	60.7 years STANDARD_DEVIATION 7.9 • n=31 Participants
Sex: Female, Male Female	32 Participants n=99 Participants	35 Participants n=107 Participants	23 Participants n=206 Participants	23 Participants n=7 Participants	113 Participants n=31 Participants
Sex: Female, Male Male	44 Participants n=99 Participants	40 Participants n=107 Participants	20 Participants n=206 Participants	22 Participants n=7 Participants	126 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	3 Participants n=31 Participants
Race (NIH/OMB) White	74 Participants n=99 Participants	74 Participants n=107 Participants	43 Participants n=206 Participants	45 Participants n=7 Participants	236 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Region of Enrollment United States	76 participants n=99 Participants	75 participants n=107 Participants	43 participants n=206 Participants	45 participants n=7 Participants	239 participants n=31 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Among participants with with rectal mucosa and rectal swab and stool samples.

Outcome measures

Outcome measures
Measure	GG Genotype and Magnesium Treatment n=73 Participants Participants who have the GG genotype will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GG Genotype and Placebo n=70 Participants Participants who have the GG genotype will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks	GA/AA Genotype and Magnesium Treatment n=42 Participants Participants who have the GA/AA genotype will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GA/AA Genotype and Placebo n=44 Participants Participants who have the GA/AA genotype will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples Rectal Mucosa	0.108 percentage of sample Standard Error 2.268	0.245 percentage of sample Standard Error 2.686	-0.076 percentage of sample Standard Error 2.355	0.132 percentage of sample Standard Error 2.034
Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples Rectal Swab	-0.174 percentage of sample Standard Error 1.954	-0.095 percentage of sample Standard Error 2.239	-0.919 percentage of sample Standard Error 2.165	0.364 percentage of sample Standard Error 2.111
Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples Stool	-0.059 percentage of sample Standard Error 1.716	-0.001 percentage of sample Standard Error 1.814	0.363 percentage of sample Standard Error 1.276	0.137 percentage of sample Standard Error 1.639

PRIMARY outcome

Timeframe: 12 weeks

Population: Among participants with with rectal mucosa and rectal swab and stool samples.

Outcome measures

Outcome measures
Measure	GG Genotype and Magnesium Treatment n=73 Participants Participants who have the GG genotype will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GG Genotype and Placebo n=70 Participants Participants who have the GG genotype will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks	GA/AA Genotype and Magnesium Treatment n=42 Participants Participants who have the GA/AA genotype will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GA/AA Genotype and Placebo n=44 Participants Participants who have the GA/AA genotype will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples Rectal mucosa	-0.030 percentage of sample Standard Error 0.205	-0.027 percentage of sample Standard Error 0.252	0.039 percentage of sample Standard Error 0.208	-0.025 percentage of sample Standard Error 0.196
Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples Rectal swab	0.024 percentage of sample Standard Error 0.413	-0.013 percentage of sample Standard Error 0.465	-0.041 percentage of sample Standard Error 0.355	-0.017 percentage of sample Standard Error 0.283
Comparisons of the Changes of Genera Bacteroides by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples Stool	-0.063 percentage of sample Standard Error 0.536	0.022 percentage of sample Standard Error 0.410	-0.105 percentage of sample Standard Error 0.377	0.084 percentage of sample Standard Error 0.418

Adverse Events

GG Genotype and Magnesium Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

GG Genotype and Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

GA/AA Genotype and Magnesium Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

GA/AA Genotype and 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

Other adverse events
Measure	GG Genotype and Magnesium Treatment n=77 participants at risk Participants who have the GG genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GG Genotype and Placebo n=78 participants at risk Participants who have the GG genotype were assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks	GA/AA Genotype and Magnesium Treatment n=47 participants at risk Participants who have the GA/AA genotype were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	GA/AA Genotype and Placebo n=48 participants at risk Participants who have the GA/AA genotype were assigned to placebo group 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.
General 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

Dr. Martha Shrubsole, Dr. Qi Dai

Vanderbilt University Medical Center

Phone: (615)936-0707

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place