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Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards

Primary Purpose

Hypomagnesemia

Status
Recruiting
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Magnesium Citrate 100 MG
Sponsored by
Frieda Wolf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypomagnesemia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient admitted over the age of 18, has hypomagnesemia (magnesium level ≤1.9 mg/dL) and is able to give consent.

Exclusion Criteria:

  • A patient unable to give consent.
  • A patient admitted for an elective procedure.
  • A patient in critical condition or dying.
  • Patients with advanced kidney disease with eGFR<15ml/min or on dialysis.
  • Patients with severe diarrhea, precluding use of magnesium citrate.
  • Patients already receiving magnesium supplements.
  • Patients with severe malnutrition or life-threatening hypomagnesemia (serum level <1mg/dL), requiring intravenous and oral replacement of magnesium.

Sites / Locations

  • Emek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Experimental group

Control group

Arm Description

After initial intravenous treatment, participants (those with magnesium level ≥1 mg/dL) will be randomized, and oral magnesium therapy ( or no treatment) will be started. The experimental group will receive 400mg magnesium daily in two divided doses. Patients in the experimental group will be discharged with one month's supply of magnesium and continued for at least three months.

control group will receive standard care (no treatment). Patient will have their blood tested and will come for follow up visit every month for 3 months after discharge.

Outcomes

Primary Outcome Measures

compare mortality
To compare mortality between the population receiving magnesium and the population receiving standard care: ie no replacement.

Secondary Outcome Measures

Hospitalization
Length in days of hospitalization.

Full Information

First Posted
October 27, 2016
Last Updated
March 16, 2022
Sponsor
Frieda Wolf
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1. Study Identification

Unique Protocol Identification Number
NCT03088852
Brief Title
Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards
Official Title
Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frieda Wolf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypomagnesemia is a common entity in the inpatient and outpatient setting. in previous retrospective study hypomagnesemic patients have higher mortality and longer hospitalization. whether hypomagnesemia is merely a marker of poor prognosis, or whether replacing it can improve outcomes is unclear. The current standard of care is to discharge these patients without workup or further treatment, even if patients had received intravenous therapy while hospitalized. The investigator wish to examine prospectively whether giving replacement therapy affects mortality, length of hospital stay and overall well-being. In order to replete intracellular levels and replete magnesium stores, magnesium should be given for several months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypomagnesemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
After initial intravenous treatment, participants (those with magnesium level ≥1 mg/dL) will be randomized, and oral magnesium therapy ( or no treatment) will be started. The experimental group will receive 400mg magnesium daily in two divided doses. Patients in the experimental group will be discharged with one month's supply of magnesium and continued for at least three months.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
control group will receive standard care (no treatment). Patient will have their blood tested and will come for follow up visit every month for 3 months after discharge.
Intervention Type
Drug
Intervention Name(s)
Magnesium Citrate 100 MG
Other Intervention Name(s)
Diasporal
Intervention Description
initial intravenous treatment: Patients with magnesium levels 1-1.5 mg/dL will receive 2-4 grams of magnesium sulfate in the first 24 hours. Patients with magnesium levels 1.6-1.9 mg/dL will receive 1 gram of magnesium sulfate. participants with magnesium level ≥1 mg/dL, will be randomized, and oral magnesium therapy, Magnesium Citrate, ( or no treatment) will be started, and continued for at least three months. The experimental group will receive 400mg magnesium daily in two divided doses.
Primary Outcome Measure Information:
Title
compare mortality
Description
To compare mortality between the population receiving magnesium and the population receiving standard care: ie no replacement.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Hospitalization
Description
Length in days of hospitalization.
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
causes for hypomagnesemia
Description
The investigators will attempt to ascertain the causes for hypomagnesemia from the data collected (medications, diarrhea, malnutrition, etc)
Time Frame
one year
Title
re-hospitalization
Description
re-hospitalization for any cause
Time Frame
one year
Title
Subjective well-being
Description
symptoms and overall well-being of the patients: a questionaire will be administered at the beginning of the study and at each visit regarding subjective feelings of well being, symptoms of pain, cramping and diarrhea, and overall functional capacity
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient admitted over the age of 18, has hypomagnesemia (magnesium level ≤1.9 mg/dL) and is able to give consent. Exclusion Criteria: A patient unable to give consent. A patient admitted for an elective procedure. A patient in critical condition or dying. Patients with advanced kidney disease with eGFR<15ml/min or on dialysis. Patients with severe diarrhea, precluding use of magnesium citrate. Patients already receiving magnesium supplements. Patients with severe malnutrition or life-threatening hypomagnesemia (serum level <1mg/dL), requiring intravenous and oral replacement of magnesium.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frieda Wolf
Phone
972-4-6495476
Email
friedawo@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Rotem Shvartzman
Phone
972-4-6495351
Email
rotem_sw@clait.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frieda Wolf
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emek Medical Center
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frieda Wolf, MD
Phone
972502285400
Email
friedawolf@hotmail.com
First Name & Middle Initial & Last Name & Degree
Rotem Scwartz
Phone
97246495351
Email
rotem_sw@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22404119
Citation
Weglicki WB. Hypomagnesemia and inflammation: clinical and basic aspects. Annu Rev Nutr. 2012 Aug 21;32:55-71. doi: 10.1146/annurev-nutr-071811-150656. Epub 2012 Mar 8.
Results Reference
background
PubMed Identifier
20513641
Citation
Rayssiguier Y, Libako P, Nowacki W, Rock E. Magnesium deficiency and metabolic syndrome: stress and inflammation may reflect calcium activation. Magnes Res. 2010 Jun;23(2):73-80. doi: 10.1684/mrh.2010.0208. Epub 2010 May 31.
Results Reference
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PubMed Identifier
23846901
Citation
Chaigne-Delalande B, Li FY, O'Connor GM, Lukacs MJ, Jiang P, Zheng L, Shatzer A, Biancalana M, Pittaluga S, Matthews HF, Jancel TJ, Bleesing JJ, Marsh RA, Kuijpers TW, Nichols KE, Lucas CL, Nagpal S, Mehmet H, Su HC, Cohen JI, Uzel G, Lenardo MJ. Mg2+ regulates cytotoxic functions of NK and CD8 T cells in chronic EBV infection through NKG2D. Science. 2013 Jul 12;341(6142):186-91. doi: 10.1126/science.1240094.
Results Reference
background
PubMed Identifier
26268579
Citation
Misra PS, Alam A, Lipman ML, Nessim SJ. The relationship between proton pump inhibitor use and serum magnesium concentration among hemodialysis patients: a cross-sectional study. BMC Nephrol. 2015 Aug 13;16:136. doi: 10.1186/s12882-015-0139-9.
Results Reference
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Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards

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