EpilepsyNCT03471481
Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy
An observational study of Epilepsy and Magnesium Deficiency, run by Drexel University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy, Magnesium Deficiency, Vitamin D Deficiency
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2015to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals diagnosed with epilepsy and on medications
Who may be able to join
- Individuals receiving anti-epileptic drugs as a treatment for epilepsy
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Drexel University Nutrition Sciences Research Lab
Philadelphia, Pennsylvania, 19102
Drexel University
Philadelphia, Pennsylvania, 19102
About this study
The objective of this study is to determine the role of magnesium on bone and vitamin D metabolism in patients receiving anti-epileptic medications.
- Conditions
- Epilepsy, Magnesium Deficiency, Vitamin D Deficiency
- Being tested
- No Intervention. Study is Cross Sectional in nature
- Medical subject headings
- Epilepsy, Magnesium Deficiency, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention. Study is Cross Sectional in natureOther
No Intervention. Study is cross sectional in nature
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Will be measured at Tibia, Hip and Total Body using a DXA scan
Measured: 1 time point - baseline
Secondary outcomes (2)
Ionized Magnesium in serum
This will be assayed in the serum
Measured: 1 time point - baseline
Vitamin D - 25 hydroxy vitamin D
This will be assayed in the serum
Measured: 1 time point - baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start10 Aug 2015
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Why it stopped: Closure of Drexel University Hahnemann Hospital where Referring Physician Worked
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471481
- Sponsor's protocol ID
- 150003722
- Status last verified
- Nov 2019
- First submitted
- 14 Mar 2018
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy
- ClinicalTrials.gov ID
- NCT03471481
- Acronym / sponsor ID
- 150003722
- Conditions
- Epilepsy, Magnesium Deficiency, Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Closure of Drexel University Hahnemann Hospital where Referring Physician Worked
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 10 Aug 2015 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with epilepsy and on medications
Key inclusion criteria (1 listed)
- Individuals receiving anti-epileptic drugs as a treatment for epilepsy
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention. Study is Cross Sectional in natureNo Intervention. Study is cross sectional in nature | Other | – |
Primary outcome
Bone mineral density
Time frame: 1 time point - baseline
Will be measured at Tibia, Hip and Total Body using a DXA scan
2 secondary outcomes
Ionized Magnesium in serum
Time frame: 1 time point - baseline
Vitamin D - 25 hydroxy vitamin D
Time frame: 1 time point - baseline
Results and safety
The study was stopped early (reason given: Closure of Drexel University Hahnemann Hospital where Referring Physician Worked). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Magnesium Deficiency, run by Drexel University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Closure of Drexel University Hahnemann Hospital where Referring Physician Worked). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 1 time point - baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.