An interventional study of Magnesium glycinate and Placebo in Colorectal Cancer, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Prevention
One striking observation is that a large portion of the inter-person variation in serum 25-hydroxyvitamin D (25(OH)D) levels is unexplained. In vitro and in vivo studies indicate vitamin D synthesizing and metabolizing enzymes are Mg-dependent. Magnesium (Mg) supplementation substantially reversed the resistance to vitamin D treatment in patients with magnesium-dependent vitamin-D-resistant rickets. The investigators reported in 2013 from observational studies conducted in the general US population that Mg intake significantly interacted with vitamin D intake in affecting vitamin D status as well as interacted with serum 25(OH)D in risk of cardiovascular disease mortality and, maybe, colorectal cancer mortality. The potential interaction between Mg and vitamin D was supported by two subsequent studies, including a Finnish cohort study and a mouse study.
In the parent study (Personalized Prevention of Colorectal Cancer Trial, NCT01105169), the investigators proposed to measure blood concentration of total 25(OH)D as a secondary aim using Elisa approach. However, following the novel finding of Mg-vitamin D interaction published by the investigators in 2013, they submitted a separate grant application to NCI which was funded in 2014. In the new study, the investigators proposed to use a LC-MS approach, which is more accurate and specific than an Elisa method, to measure 5 vitamin D metabolites. This new ancillary study allows the investigators to evaluate whether Mg supplementation differentially affects vitamin D synthesis and metabolism dependent on baseline serum 25(OH)D levels using existing biospecimens collected in our double-blind placebo-controlled randomized chemoprevention trial.
Exclusion Criteria:
Participants will be assigned to magnesium glycinate
Dietary Supplement: Magnesium glycinate
Participants will be assigned to placebo group
Dietary Supplement: Placebo
Oral administration of magnesium glycinate daily for 12 weeks
Oral administration of identical-appearing placebo daily for 12 weeks
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
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).
Time frame: 12 weeks
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
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).
Time frame: 12 weeks
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
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).
Time frame: 12 weeks
| Milestone | Magnesium Glycinate Supplements | Placebo |
|---|---|---|
| Started | 87 | 93 |
| Completed | 87 | 93 |
| Not completed | 0 | 0 |
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).
| ng/mL | The Changes in Magnesium Treatment Arm | The Changes in Placebo Arm |
|---|---|---|
| Baseline 25(OH)D=30 | 32.20 ± 1.56 | 29.41 ± 1.61 |
| Baseline 25(OH)D=20 | 30.95 ± 2.18 | 29.37 ± 2.08 |
| Baseline 25(OH)D=40 | 29.76 ± 1.84 | 30.31 ± 1.80 |
| Baseline 25(OH)D=50 | 24.89 ± 2.74 | 31.76 ± 2.00 |
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).
| ng/mL (log-transformed) | The Changes in Magnesium Treatment Arm | The Changes in Placebo Arm |
|---|---|---|
| Baseline 25(OH)D=20 | -2.22 ± 0.57 | -1.65 ± 0.55 |
| Baseline 25(OH)D=30 | -1.94 ± 0.45 | -1.38 ± 0.46 |
| Baseline 25(OH)D=40 | -1.68 ± 0.44 | -2.13 ± 0.45 |
| Baseline 25(OH)D=50 | -1.43 ± 0.55 | -3.56 ± 0.57 |
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).
| ng/mL | The Changes in Magnesium Treatment Arm | The Changes in Placebo Arm |
|---|---|---|
| Baseline 25(OH)D=20 | 4.35 ± 0.41 | 3.96 ± 0.39 |
| Baseline 25(OH)D=30 | 4.31 ± 0.32 | 3.90 ± 0.32 |
| Baseline 25(OH)D=40 | 3.47 ± 0.32 | 3.91 ± 0.32 |
| Baseline 25(OH)D=50 | 2.12 ± 0.44 | 3.97 ± 0.36 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Magnesium Supplements | 0/87 (0%) | 0/87 (0%) | 0/87 (0%) |
| Placebo | 0/93 (0%) | 0/93 (0%) | 0/93 (0%) |
This is an NCI-funded ancillary study nested in the parent study (registered at clinicaltrials.gov as NCT01105169). For the current study, 180 participants who had completed the parent study by October 2015 were selected, including 87 participants in the treatment arm and 93 in the placebo arm. Based on the proposal, we compared the vitamin D metabolites between the two arms (magnesium treatment vs placebo).
| Age, Continuous(years) | Magnesium Glycinate Supplements | Placebo | Total |
|---|---|---|---|
| Mean | 60.4 ± 8.3 | 61.7 ± 8.3 | 61.1 ± 8.3 |
| Sex: Female, Male(Participants) | Magnesium Glycinate Supplements | Placebo | Total |
|---|---|---|---|
| Female | 42 | 48 | 90 |
| Male | 45 | 45 | 90 |
| Race (NIH/OMB)(Participants) | Magnesium Glycinate Supplements | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 85 | 92 | 177 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Vanderbilt University Medical Center