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Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03471481
Recruitment Status : Unknown
Verified August 2018 by Drexel University.
Recruitment status was:  Recruiting
First Posted : March 20, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Drexel University

Brief Summary:
The objective of this study is to determine the role of magnesium on bone and vitamin D metabolism in patients receiving anti-epileptic medications.

Condition or disease Intervention/treatment
Epilepsy Magnesium Deficiency Vitamin D Deficiency Other: No Intervention. Study is Cross Sectional in nature

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy
Actual Study Start Date : August 10, 2015
Estimated Primary Completion Date : August 10, 2020
Estimated Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D


Intervention Details:
  • Other: No Intervention. Study is Cross Sectional in nature
    No Intervention. Study is cross sectional in nature


Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: 1 time point - baseline ]
    Will be measured at Tibia, Hip and Total Body using a DXA scan


Secondary Outcome Measures :
  1. Ionized Magnesium in serum [ Time Frame: 1 time point - baseline ]
    This will be assayed in the serum

  2. Vitamin D - 25 hydroxy vitamin D [ Time Frame: 1 time point - baseline ]
    This will be assayed in the serum


Biospecimen Retention:   Samples With DNA
Serum and urine samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals diagnosed with epilepsy and on medications
Criteria

Inclusion Criteria:

  • Individuals receiving anti-epileptic drugs as a treatment for epilepsy

Exclusion Criteria:

  • Individuals who are pregnant or breastfeeding, receiving cancer treatments, have liver or kidney diseases, autoimmune diseases, or other diseases that may interfere with vitamin D and magnesium metabolism.

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): NCT03471481


Contacts
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Contact: Sukumar Deeptha, PhD 267 359 5854 deeptha.sukumar@drexel.edu
Contact: May Cheung, BS 267 359 5966 mmc372@drexel.edu

Locations
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United States, Pennsylvania
Drexel University Nutrition Sciences Research Lab Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Deeptha Sukumar, PhD    267-359-5854    deeptha.sukumar@drexel.edu   
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Arun Ramakrishnan, PhD    215-553-7018    arun@drexel.edu   
Sponsors and Collaborators
Drexel University
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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT03471481    
Other Study ID Numbers: 150003722
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Magnesium Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders