Magnesium as a Mediator of Bone and Vitamin D Metabolism... | NCT03471481

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

NCT03471481

Sponsor

Drexel University

Status

Terminated

Last Update Posted

Mar 1, 2021Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Epilepsy
Magnesium Deficiency
Vitamin D Deficiency

Interventions

No Intervention. Study is Cross Sectional in nature

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Closure of Drexel University Hahnemann Hospital where Referring Physician Worked

Expanded Access Info

Start Date

Aug 10, 2015Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Mar 14, 2018

First Submission Date that Met QC Criteria

Mar 14, 2018

First Posted Date

Mar 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2021

Last Update Posted Date

Mar 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention. Study is Cross Sectional in nature	Other	No Intervention. Study is cross sectional in nature

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Individuals diagnosed with epilepsy and on medications

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Drexel University Nutrition Sciences Research Lab		Philadelphia	Pennsylvania	19102	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D008275	Magnesium Deficiency
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D003677	Deficiency Diseases

Browse Leaves

Not provided

Browse Branches

Not provided