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

February 25, 2021 updated by: Drexel University
The objective of this study is to determine the role of magnesium on bone and vitamin D metabolism in patients receiving anti-epileptic medications.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University Nutrition Sciences Research Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals diagnosed with epilepsy and on medications

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density
Time Frame: 1 time point - baseline
Will be measured at Tibia, Hip and Total Body using a DXA scan
1 time point - baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ionized Magnesium in serum
Time Frame: 1 time point - baseline
This will be assayed in the serum
1 time point - baseline
Vitamin D - 25 hydroxy vitamin D
Time Frame: 1 time point - baseline
This will be assayed in the serum
1 time point - baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 10, 2015

Primary Completion (ACTUAL)

August 1, 2019

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (ACTUAL)

March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150003722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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