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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

Tracking Information
First Submitted Date  ICMJE August 25, 2017
First Posted Date  ICMJE August 29, 2017
Last Update Posted Date August 30, 2017
Actual Study Start Date  ICMJE September 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03265483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnesium Treatment on Vitamin D Metabolism in Participants Completed Personalized Prevention of Colorectal Cancer Trial
Official Title  ICMJE Effect of Magnesium Treatment on Vitamin D Resistance
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Dietary Supplement: Magnesium glycinate
    Oral administration of magnesium glycinate daily for 12 weeks
  • Dietary Supplement: Placebo
    Oral administration of identical-appearing placebo daily for 12 weeks
Study Arms  ICMJE
  • Active Comparator: GG genotype and magnesium treatment
    Participants who have the GG genotype will be assigned to magnesium glycinate
    Intervention: Dietary Supplement: Magnesium glycinate
  • Placebo Comparator: GG genotype and placebo
    Participants who have the GG genotype will be assigned to placebo group
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: GA/AA genotype and magnesium treatment
    Participants who have the GA/AA genotype will be assigned to magnesium glycinate
    Intervention: Dietary Supplement: Magnesium glycinate
  • Placebo Comparator: GA/AA genotype and Placebo
    Participants who have the GA/AA genotype will be assigned to placebo group
    Intervention: Dietary Supplement: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2017)
180
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03265483
Other Study ID Numbers  ICMJE 100106b
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martha Shrubsole, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vanderbilt University Medical Center
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP