Study Stopped
Closure of Drexel University Hahnemann Hospital where Referring Physician Worked
Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy
1 other identifier
observational
7
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2015
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2015
CompletedFirst Submitted
Initial submission to the registry
March 14, 2018
CompletedFirst Posted
Study publicly available on registry
March 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMarch 1, 2021
November 1, 2019
4 years
March 14, 2018
February 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Bone mineral density
Will be measured at Tibia, Hip and Total Body using a DXA scan
1 time point - baseline
Secondary Outcomes (2)
Ionized Magnesium in serum
1 time point - baseline
Vitamin D - 25 hydroxy vitamin D
1 time point - baseline
Interventions
No Intervention. Study is cross sectional in nature
Eligibility Criteria
Individuals diagnosed with epilepsy and on medications
You may qualify if:
- Individuals receiving anti-epileptic drugs as a treatment for epilepsy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Drexel University Nutrition Sciences Research Lab
Philadelphia, Pennsylvania, 19102, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
Biospecimen
Serum and urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2018
First Posted
March 20, 2018
Study Start
August 10, 2015
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
March 1, 2021
Record last verified: 2019-11