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

• Sponsor: Drexel University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03471481
• Collaborator: (none)
• Enrollment: 7
• Locations: 2
• Actual Duration (Months): 47.7
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Phase
Epilepsy; Magnesium Deficiency; Vitamin D Deficiency	Other: No Intervention. Study is Cross Sectional in nature

Study Design

• Study Type: Observational
• Actual Enrollment: 7 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: Aug 10, 2015
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Outcome Measures

Primary Outcome Measures

1. Bone mineral density [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 [1 time point - baseline]

   This will be assayed in the serum

2. Vitamin D - 25 hydroxy vitamin D [1 time point - baseline]

   This will be assayed in the serum

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Drexel University Nutrition Sciences Research Lab	Philadelphia	Pennsylvania	United States	19102
2	Drexel University	Philadelphia	Pennsylvania	United States	19102

Sponsors and Collaborators

• Drexel University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Drexel University
• ClinicalTrials.gov Identifier: NCT03471481
• Other Study ID Numbers: 150003722
• First Posted: Mar 20, 2018
• Last Update Posted: Mar 1, 2021
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vitamin D Deficiency; Magnesium Deficiency

Study Results

No Results Posted as of Mar 1, 2021