Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards

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.

Study Overview

• Status: Recruiting
• Conditions: Hypomagnesemia
• Intervention / Treatment: Drug: Magnesium Citrate 100 MG

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Frieda Wolf; Phone Number: 972-4-6495476; Email: friedawo@clalit.org.il
• Study Contact Backup: Name: Rotem Shvartzman; Phone Number: 972-4-6495351; Email: rotem_sw@clait.org.il

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • Emek Medical Center
    • Contact: Frieda Wolf, MD; Phone Number: 972502285400; Email: friedawolf@hotmail.com
    • Contact: Rotem Scwartz; Phone Number: 97246495351; Email: rotem_sw@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental group; 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.	Drug: Magnesium Citrate 100 MG; 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.; Other Names: Diasporal
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare mortality	To compare mortality between the population receiving magnesium and the population receiving standard care: ie no replacement.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	Length in days of hospitalization.	one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
causes for hypomagnesemia	The investigators will attempt to ascertain the causes for hypomagnesemia from the data collected (medications, diarrhea, malnutrition, etc)	one year
re-hospitalization	re-hospitalization for any cause	one year
Subjective well-being	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	one year

Collaborators and Investigators

• Sponsor: Frieda Wolf
• Investigators: Principal Investigator: Frieda Wolf, HaEmek Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: March 19, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Magnesium Deficiency; Gastrointestinal Agents; Cathartics; Magnesium citrate
• Other Study ID Numbers: EMC 70-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No