Trial Outcomes & Findings for Ca:Mg Ratio and Cognitive Function (NCT NCT04196023)
NCT ID: NCT04196023
Last Updated: 2024-05-21
Results Overview
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-05-21
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 completed MoCA assessment were recruited from Vanderbilt patient sources from Dec. 12, 2012 to Jan 30, 2016.
Participant milestones
| Measure |
Participants Were Assigned to Magnesium Glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Participants Were Assigned to Placebo
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
67
|
|
Overall Study
COMPLETED
|
59
|
64
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Participants Were Assigned to Magnesium Glycinate
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Participants Were Assigned to Placebo
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Ca:Mg Ratio and Cognitive Function
Baseline characteristics by cohort
| Measure |
Participants Will be Assigned to Magnesium Glycinate
n=62 Participants
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Participants Will be Assigned to Placebo
n=67 Participants
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 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
|
60 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
126 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
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
67 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Overall MoCA Score at Baseline
|
27.0 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
27.2 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
27.1 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: IRB approval was obtained to add the MoCA component on Dec.11 2012. From Dec. 12, 2012 to Jan 30, 2016, 129 participants enrolled the study. Among them, 123 (95.3%) completed pre-and post- treatment MoCA were included in the analysis.
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Outcome measures
| Measure |
Participants Were Assigned to Magnesium Glycinate
n=59 Participants
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Participants Were Assigned to Placebo
n=64 Participants
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo
|
1.1 score on a scale
Standard Deviation 2.3
|
0.6 score on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 123 participants who completed both pre- and post-treatment MoCA tests are included in the analysis.
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Outcome measures
| Measure |
Participants Were Assigned to Magnesium Glycinate
n=44 Participants
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Participants Were Assigned to Placebo
n=49 Participants
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged ≤65 Years Old)
|
0.7 score on a scale
Standard Deviation 2.0
|
0.6 score on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 123 participants who completed pre-and post- treatment MoCA were included in the analysis.
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Outcome measures
| Measure |
Participants Were Assigned to Magnesium Glycinate
n=15 Participants
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Participants Were Assigned to Placebo
n=15 Participants
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged >65 Years Old)
|
2.3 score on a scale
Standard Deviation 2.7
|
0.5 score on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 123 participants who completed both pre- and post-treatment MoCA tests were included in the analysis.
5-mC methylation (CpG sites) in Apolipoprotein E (APOE) were measure by TET-assisted bisulfite (TAB)-Array. 5-mC methylation changes=value at 12 weeks minus value at baseline.
Outcome measures
| Measure |
Participants Were Assigned to Magnesium Glycinate
n=59 Participants
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Participants Were Assigned to Placebo
n=64 Participants
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Changes From Baseline of 5-mC Methylation (CpG Sites) in Apolipoprotein E (APOE) by Magnesium Treatment vs. Placebo
cg18768621
|
0.006 CpG sites
Standard Deviation 0.025
|
-0.003 CpG sites
Standard Deviation 0.025
|
|
Changes From Baseline of 5-mC Methylation (CpG Sites) in Apolipoprotein E (APOE) by Magnesium Treatment vs. Placebo
cg13496662
|
-0.018 CpG sites
Standard Deviation 0.060
|
0.006 CpG sites
Standard Deviation 0.067
|
Adverse Events
Participants Were Assigned to Magnesium Glycinate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Participants Were Assigned to Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants Were Assigned to Magnesium Glycinate
n=62 participants at risk
Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks
|
Participants Were Assigned to Placebo
n=67 participants at risk
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
some bleeding after the rectal biopsy procedure
|
0.00%
0/62 • 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.
|
1.5%
1/67 • 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
Abdominal pain
|
1.6%
1/62 • 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.
|
1.5%
1/67 • 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.
|
|
Vascular disorders
may interact with blood pressure medication
|
1.6%
1/62 • 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%
0/67 • 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
|
1.6%
1/62 • 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%
0/67 • 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
|
1.6%
1/62 • 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%
0/67 • 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