Colorectal CancerNCT03265483

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

A study testing Magnesium glycinate in people with Colorectal Cancer, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer
What is being tested?: Magnesium glycinate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Aug 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);
Participants who had completed the above study before the time of the sample selection (October 2015);
Participants consent to store/share samples for future research in colorectal tumors.

Who cannot join

1. Participants cannot provide their blood samples in the parent study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Effect of Magnesium Treatment on Vitamin D Resistance

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.

Conditions: Colorectal Cancer
Being tested: Magnesium glycinate, Placebo
Keywords: Personalized prevention trial, Magnesium, Vitamin D metabolism and synthesis, Magnesium-vitamin D interaction
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnesium glycinateDietary supplement
Oral administration of magnesium glycinate daily for 12 weeks
PlaceboDietary supplement
Oral administration of identical-appearing placebo daily for 12 weeks

Study groups in NCT03265483
Study group	Role	What they receive
Magnesium treatment	Active comparator	Participants will be assigned to magnesium glycinate Receives: Dietary Supplement: Magnesium glycinate
Placebo	Placebo comparator	Participants will be assigned to placebo group Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Aug 2016

First posted29 Aug 2017
Study startSep 2014
Primary completionAug 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03265483
Sponsor's protocol ID: 100106b
Status last verified: Aug 2024
First submitted: 25 Aug 2017
Last updated: 23 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Sun E, Zhu X, Ness RM, Murff HJ, Sun S, Yu C, Fan L, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Magnesium treatment increases gut microbiome synthesizing vitamin D and inhibiting colorectal cancer: results from a double-blind precision-based randomized placebo-controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1185-1194. doi: 10.1016/j.ajcnut.2025.09.011. Epub 2025 Sep 12.
PubMed 40946805
Zhu X, Borenstein AR, Zheng Y, Zhang W, Seidner DL, Ness R, Murff HJ, Li B, Shrubsole MJ, Yu C, Hou L, Dai Q. Ca:Mg Ratio, APOE Cytosine Modifications, and Cognitive Function: Results from a Randomized Trial. J Alzheimers Dis. 2020;75(1):85-98. doi: 10.3233/JAD-191223.
PubMed 32280092
Dai Q, Zhu X, Manson JE, Song Y, Li X, Franke AA, Costello RB, Rosanoff A, Nian H, Fan L, Murff H, Ness RM, Seidner DL, Yu C, Shrubsole MJ. Magnesium status and supplementation influence vitamin D status and metabolism: results from a randomized trial. Am J Clin Nutr. 2018 Dec 1;108(6):1249-1258. doi: 10.1093/ajcn/nqy274.
PubMed 30541089

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Magnesium Treatment on Vitamin D Resistance
ClinicalTrials.gov ID: NCT03265483
Acronym / sponsor ID: 100106b
Conditions: Colorectal Cancer
Keywords: Personalized prevention trial, Magnesium, Vitamin D metabolism and synthesis, Magnesium-vitamin D interaction
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: Sep 2014 (actual)
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 29 Aug 2017 (actual)
Results: Posted 23 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Magnesium treatment	Active comparator	Dietary Supplement: Magnesium glycinateParticipants will be assigned to magnesium glycinate
Placebo	Placebo comparator	Dietary Supplement: PlaceboParticipants will be assigned to placebo group

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);
Participants who had completed the above study before the time of the sample selection (October 2015);
Participants consent to store/share samples for future research in colorectal tumors.

Key exclusion criteria (1 listed)

1. Participants cannot provide their blood samples in the parent study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Magnesium glycinateOral administration of magnesium glycinate daily for 12 weeks	Dietary supplement	Magnesium treatment
PlaceboOral administration of identical-appearing placebo daily for 12 weeks	Dietary supplement	Placebo

Primary outcome

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
Time frame: 12 weeks
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).
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
Time frame: 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).
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
Time frame: 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).

Results and safety

Results posted to the registry on 23 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Magnesium Glycinate Supplements	87	87
Placebo	93	93

Primary outcome: 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

Time frame: 12 weeks. Mean (Standard Error). Unit: ng/mL

Measure	The Changes in Magnesium Treatment Arm n = 87	The Changes in Placebo Arm n = 93
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)

Population analysed: 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.

Primary outcome: 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

Time frame: 12 weeks. Mean (Standard Deviation). Unit: ng/mL (log-transformed)

Measure	The Changes in Magnesium Treatment Arm n = 87	The Changes in Placebo Arm n = 93
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)

Primary outcome: 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

Time frame: 12 weeks. Mean (Standard Deviation). Unit: ng/mL

Measure	The Changes in Magnesium Treatment Arm n = 87	The Changes in Placebo Arm n = 93
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)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Magnesium Supplements	0 of 87 (0%)	0 of 87 (0%)	0 of 87
Placebo	0 of 93 (0%)	0 of 93 (0%)	0 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40946805Sun E, Zhu X, Ness RM, Murff HJ, Sun S, Yu C, Fan L, Azcarate-Peril MA, Shrubsole MJ, Dai Q. Magnesium treatment increases gut microbiome synthesizing vitamin D and inhibiting colorectal cancer: results from a double-blind precision-based randomized placebo-controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1185-1194. doi: 10.1016/j.ajcnut.2025.09.011. Epub 2025 Sep 12.
Derived from this study: PubMed 32280092Zhu X, Borenstein AR, Zheng Y, Zhang W, Seidner DL, Ness R, Murff HJ, Li B, Shrubsole MJ, Yu C, Hou L, Dai Q. Ca:Mg Ratio, APOE Cytosine Modifications, and Cognitive Function: Results from a Randomized Trial. J Alzheimers Dis. 2020;75(1):85-98. doi: 10.3233/JAD-191223.
Derived from this study: PubMed 30541089Dai Q, Zhu X, Manson JE, Song Y, Li X, Franke AA, Costello RB, Rosanoff A, Nian H, Fan L, Murff H, Ness RM, Seidner DL, Yu C, Shrubsole MJ. Magnesium status and supplementation influence vitamin D status and metabolism: results from a randomized trial. Am J Clin Nutr. 2018 Dec 1;108(6):1249-1258. doi: 10.1093/ajcn/nqy274.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Magnesium glycinate in people with Colorectal Cancer, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03265483, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.