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

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ClinicalTrials.gov Identifier: NCT03265483
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Martha Shrubsole, Vanderbilt University Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: Magnesium glycinate Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Magnesium Treatment on Vitamin D Resistance
Actual Study Start Date : September 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GG genotype and magnesium treatment
Participants who have the GG genotype will be assigned to magnesium glycinate
Dietary Supplement: Magnesium glycinate
Oral administration of magnesium glycinate daily for 12 weeks

Placebo Comparator: GG genotype and placebo
Participants who have the GG genotype will be assigned to placebo group
Dietary Supplement: Placebo
Oral administration of identical-appearing placebo daily for 12 weeks

Active Comparator: GA/AA genotype and magnesium treatment
Participants who have the GA/AA genotype will be assigned to magnesium glycinate
Dietary Supplement: Magnesium glycinate
Oral administration of magnesium glycinate daily for 12 weeks

Placebo Comparator: GA/AA genotype and Placebo
Participants who have the GA/AA genotype will be assigned to placebo group
Dietary Supplement: Placebo
Oral administration of identical-appearing placebo daily for 12 weeks




Primary Outcome Measures :
  1. Blood 25-Hydroxyvitamin D3 [ Time Frame: 12 weeks ]
    25-Hydroxyvitamin D3 was extracted from plasma by liquid extraction and measured by using a novel liquid chromatography-mass spectrometry (LC-MS) method.

  2. Blood 25-Hydroxyvitamin D2 [ Time Frame: 12 weeks ]
    25-Hydroxyvitamin D3 was extracted from plasma by liquid extraction, and measured by using a novel liquid chromatography-mass spectrometry (LC-MS) method

  3. Blood 24,25-Dihydroxycholecalciferol (24,25-dihydroxyvitamin D3) [ Time Frame: 12 weeks ]
    24,25-dihydroxyvitamin D3 was extracted from plasma by liquid extraction, and detected by using a novel liquid chromatography-mass spectrometry (LC-MS) method.

  4. Blood 1,25-dihydroxyvitamin D3 [ Time Frame: 12 weeks ]
    1,25-dihydroxyvitamin D3 was extracted from plasma using ALPCO immunoextraction kit following manufacturer's protocols. It was detected by a liquid chromatography-mass spectrometry (LC-MS) method.

  5. Blood 1,25-dihydroxyvitamin D2 [ Time Frame: 12 weeks ]
    1,25-dihydroxyvitamin D2 were extracted from plasma using ALPCO immunoextraction kit following manufacturer's protocols. It was detected by a liquid chromatography-mass spectrometry (LC-MS) method.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265483


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martha Shrubsole, Research Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03265483     History of Changes
Other Study ID Numbers: 100106b
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martha Shrubsole, Vanderbilt University Medical Center:
Personalized prevention trial
Magnesium
Vitamin D metabolism and synthesis
Magnesium-vitamin D interaction
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents