Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards

Hypomagnesemia Clinical Trial

Official title:

Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03088852
• Other study ID #: EMC 70-16
• Status: Recruiting
• Phase: Phase 4
• Start date: May 10, 2017
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: HaEmek Medical Center, Israel
• Contact: Frieda Wolf
• Phone: 972-4-6495476
• Email: friedawo[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypomagnesemia
• Magnesium Deficiency

Intervention

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.

Locations

Country	Name	City	State
Israel	Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Frieda Wolf

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	causes for hypomagnesemia	The investigators will attempt to ascertain the causes for hypomagnesemia from the data collected (medications, diarrhea, malnutrition, etc)	one year
Other	re-hospitalization	re-hospitalization for any cause	one year
Other	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
Primary	compare mortality	To compare mortality between the population receiving magnesium and the population receiving standard care: ie no replacement.	one year
Secondary	Hospitalization	Length in days of hospitalization.	one year