Trial Outcomes & Findings for Magnesium Treatment on Vitamin D Metabolism in Participants Completed Personalized Prevention of Colorectal Cancer Trial (NCT NCT03265483)

Last Updated: 2024-08-23

Results Overview

25(OH)D3 was extracted from plasma by liquid extraction and measured by using a novel liquid chromatography-mass spectrometry (LC-MS) method. The baseline 25(OH)D were measured by: the baseline value of 25(OH)D2 + the baseline value of 25(OH)D3. The changes of 25(OH)D3 were measured as: the post-treatment value of 25(OH)D3 (at Week 12) - the pre-treatment value of 25(OH)D3 (at baseline).

Recruitment status

COMPLETED

Study phase

Target enrollment

180 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	Magnesium Glycinate Supplements Participants will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	Placebo Participants will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
Overall Study STARTED	87	93
Overall Study COMPLETED	87	93
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnesium Treatment on Vitamin D Metabolism in Participants Completed Personalized Prevention of Colorectal Cancer Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magnesium Glycinate Supplements n=87 Participants Participants will be assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks	Placebo n=93 Participants Participants will be assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks	Total n=180 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 8.3 • n=5 Participants	61.7 years STANDARD_DEVIATION 8.3 • n=7 Participants	61.1 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	48 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	92 Participants n=7 Participants	177 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: What we include in Rows are not estimates in subgroups, but model-based predictions given specific values of baseline 25-hydroxyvitamin D (25(OH)D) levels. The mean prediction and its standard error are calculated using model coefficient estimates and its variance-covariance matrix, and the sample size is equal to the number of subjects used to fit the model, i.e., overall number of participants analyzed.

Outcome measures

Outcome measures
Measure	The Changes in Magnesium Treatment Arm n=87 Participants Participants in magnesium supplements: the changes of 25(OH)D3 were measured as: the post-treatment value of 25(OH)D3 (at Week 12) - the pre-treatment value of 25(OH)D3 (at baseline).	The Changes in Placebo Arm n=93 Participants Participants in placebo: the changes of 25(OH)D3 were measured as: the post-treatment value of 25(OH)D3 (at Week 12) - the pre-treatment value of 25(OH)D3 (at baseline).
Comparisons of the Changes of Blood 25-Hydroxyvitamin D3 (25(OH)D3) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=30	32.20 ng/mL Standard Error 1.56	29.41 ng/mL Standard Error 1.61
Comparisons of the Changes of Blood 25-Hydroxyvitamin D3 (25(OH)D3) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=20	30.95 ng/mL Standard Error 2.18	29.37 ng/mL Standard Error 2.08
Comparisons of the Changes of Blood 25-Hydroxyvitamin D3 (25(OH)D3) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=40	29.76 ng/mL Standard Error 1.84	30.31 ng/mL Standard Error 1.80
Comparisons of the Changes of Blood 25-Hydroxyvitamin D3 (25(OH)D3) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=50	24.89 ng/mL Standard Error 2.74	31.76 ng/mL Standard Error 2.00

PRIMARY outcome

Timeframe: 12 weeks

25(OH)D2 was extracted from plasma by liquid extraction and measured by using a novel liquid chromatography-mass spectrometry (LC-MS) method. The baseline 25(OH)D were measured by: the baseline value of 25(OH)D2 + the baseline value of 25(OH)D3. The changes of 25(OH)D2 were measured as: the post-treatment value of 25(OH)D2 (at Week 12) - the pre-treatment value of 25(OH)D2 (at baseline).

Outcome measures

Outcome measures
Measure	The Changes in Magnesium Treatment Arm n=87 Participants Participants in magnesium supplements: the changes of 25(OH)D3 were measured as: the post-treatment value of 25(OH)D3 (at Week 12) - the pre-treatment value of 25(OH)D3 (at baseline).	The Changes in Placebo Arm n=93 Participants Participants in placebo: the changes of 25(OH)D3 were measured as: the post-treatment value of 25(OH)D3 (at Week 12) - the pre-treatment value of 25(OH)D3 (at baseline).
Comparisons of the Changes of Blood 25-Hydroxyvitamin D2 (25(OH)D2) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=20	-2.22 ng/mL (log-transformed) Standard Deviation 0.57	-1.65 ng/mL (log-transformed) Standard Deviation 0.55
Comparisons of the Changes of Blood 25-Hydroxyvitamin D2 (25(OH)D2) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=30	-1.94 ng/mL (log-transformed) Standard Deviation 0.45	-1.38 ng/mL (log-transformed) Standard Deviation 0.46
Comparisons of the Changes of Blood 25-Hydroxyvitamin D2 (25(OH)D2) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=40	-1.68 ng/mL (log-transformed) Standard Deviation 0.44	-2.13 ng/mL (log-transformed) Standard Deviation 0.45
Comparisons of the Changes of Blood 25-Hydroxyvitamin D2 (25(OH)D2) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=50	-1.43 ng/mL (log-transformed) Standard Deviation 0.55	-3.56 ng/mL (log-transformed) Standard Deviation 0.57

PRIMARY outcome

Timeframe: 12 weeks

24,25(OH)2D3 was extracted from plasma by liquid extraction and detected by using a novel liquid chromatography-mass spectrometry (LC-MS) method. The baseline 25(OH)D were measured by: the baseline value of 25(OH)D2 + the baseline value of 25(OH)D3. The changes of 24,25(OH)2D3 were measured as: the post-treatment value of 24,25(OH)2D3 (at Week 12) - the pre-treatment value of 24,25(OH)2D3 (at baseline).

Outcome measures

Outcome measures
Measure	The Changes in Magnesium Treatment Arm n=87 Participants Participants in magnesium supplements: the changes of 25(OH)D3 were measured as: the post-treatment value of 25(OH)D3 (at Week 12) - the pre-treatment value of 25(OH)D3 (at baseline).	The Changes in Placebo Arm n=93 Participants Participants in placebo: the changes of 25(OH)D3 were measured as: the post-treatment value of 25(OH)D3 (at Week 12) - the pre-treatment value of 25(OH)D3 (at baseline).
Comparisons of the Changes of Blood 24,25-dihydroxyvitamin D3 (24,25(OH)2D3) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=20	4.35 ng/mL Standard Deviation 0.41	3.96 ng/mL Standard Deviation 0.39
Comparisons of the Changes of Blood 24,25-dihydroxyvitamin D3 (24,25(OH)2D3) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=30	4.31 ng/mL Standard Deviation 0.32	3.90 ng/mL Standard Deviation 0.32
Comparisons of the Changes of Blood 24,25-dihydroxyvitamin D3 (24,25(OH)2D3) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=40	3.47 ng/mL Standard Deviation 0.32	3.91 ng/mL Standard Deviation 0.32
Comparisons of the Changes of Blood 24,25-dihydroxyvitamin D3 (24,25(OH)2D3) Between Magnesium Treatment and Placebo Arm, Stratified by the Baseline 25-hydroxyvitamin D (25(OH)D) Levels Baseline 25(OH)D=50	2.12 ng/mL Standard Deviation 0.44	3.97 ng/mL Standard Deviation 0.36

Adverse Events

Magnesium Supplements

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Martha J. Shrubsole

Vanderbilt University Medical Center

Phone: (615)936-0812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place