Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards

NCT03088852 | Recruiting Phase 4

• 1 other identifier: EMC 70-16
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypomagnesemia

Outcome Measures

Primary Outcomes (1)

• compare mortality

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

  one year

Secondary Outcomes (1)

• Hospitalization

  one year

Other Outcomes (3)

• causes for hypomagnesemia

  one year

• re-hospitalization

  one year

• Subjective well-being

  one year

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

Magnesium Citrate 100 MG DRUG

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.

Also known as: Diasporal

Experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frieda Wolf: lead

Study Sites (1)

Emek Medical Center

Afula, Israel

RECRUITING

Related Publications (4)

• 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.

  PMID: 22404119 BACKGROUND

• 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.

  PMID: 20513641 BACKGROUND

• 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.

  PMID: 23846901 BACKGROUND

• 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.

  PMID: 26268579 BACKGROUND

MeSH Terms

Interventions

magnesium citrate; levulinic acid

Study Officials

• Frieda Wolf

  haemek medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frieda Wolf

CONTACT

972-4-6495476; friedawo@clalit.org.il

Rotem Shvartzman

CONTACT

972-4-6495351; rotem_sw@clait.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Physician in Internal Medicine C, Haemek Medical Center, Israel

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: March 23, 2017
• Study Start: May 10, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)