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NCT Number: NCT03265483

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Magnesium glycinate

Dietary Supplement

Oral administration of magnesium glycinate daily for 12 weeks

Placebo

Dietary Supplement

Oral administration of identical-appearing placebo daily for 12 weeks

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Effect of Magnesium Treatment on Vitamin D Resistance

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2017
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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