ClinicalTrials.gg
TerminatedNCT03471481Updated Mar 1, 2021

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

An observational study in Epilepsy, Magnesium Deficiency and Vitamin D Deficiency, sponsored by Drexel University. Terminated at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-01.

Sponsored by Drexel University · Observational

Why this study was terminated
Closure of Drexel University Hahnemann Hospital where Referring Physician Worked
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
7
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy
  • Magnesium Deficiency
  • Vitamin D Deficiency
03

In context

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's enrollment of 7 is below the median of 112 across 540 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Drexel University is the lead sponsor of 113 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals diagnosed with epilepsy and on medications

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Individuals who are pregnant or breastfeeding, receiving cancer treatments, have liver or kidney diseases, diseases, or other diseases that may interfere with vitamin D and magnesium metabolism.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
7 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherNo Intervention. Study is Cross Sectional in nature

    No Intervention. Study is cross sectional in nature

06

What researchers measure

Primary outcomes

  1. Bone mineral density

    Will be measured at Tibia, Hip and Total Body using a DXA scan

    Time frame: 1 time point - baseline

Secondary outcomes

  1. Ionized Magnesium in serum

    This will be assayed in the serum

    Time frame: 1 time point - baseline

  2. Vitamin D - 25 hydroxy vitamin D

    This will be assayed in the serum

    Time frame: 1 time point - baseline

07

Study locations

2 sites
  • Drexel University Nutrition Sciences Research Lab
    Philadelphia, Pennsylvania 19102, United States
  • Drexel University
    Philadelphia, Pennsylvania 19102, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2015 to primary completion in Aug 2019, 47 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2018
First posted
Mar 20, 2018
StartActual
Aug 10, 2015
Primary completionActual
Aug 1, 2019
CompletionActual
Aug 1, 2019
Last update
Mar 1, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03471481
Lead sponsor
Drexel University
Responsible party
Sponsor
First posted
Mar 20, 2018
Start date
Aug 10, 2015
Primary completion
Aug 1, 2019
Completion
Aug 1, 2019
Last update
Mar 1, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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