Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards

NCT ID: NCT03088852

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Magnesium Citrate 100 MG

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Diasporal

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frieda Wolf

OTHER

Sponsor Role: lead

Responsible Party

Frieda Wolf

Senior Physician in Internal Medicine C, Haemek Medical Center, Israel

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Frieda Wolf

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

Emek Medical Center

Afula, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Frieda Wolf

Role: CONTACT

friedawo@clalit.org.il

972-4-6495476

Rotem Shvartzman

Role: CONTACT

rotem_sw@clait.org.il

972-4-6495351

Facility Contacts

Frieda Wolf, MD

Role: primary

friedawolf@hotmail.com

972502285400

Rotem Scwartz

Role: backup

rotem_sw@clalit.org.il

97246495351

References

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.

Reference Type: BACKGROUND

PMID: 22404119 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20513641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23846901 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26268579 (View on PubMed)

Other Identifiers

EMC 70-16

Identifier Type: -

Identifier Source: org_study_id