Clinical trial NCT03088852: Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards
Official title: Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypomagnesemia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: compare mortality
timeFrame: one year
Secondary outcomes:
measure: Hospitalization
timeFrame: one year
Other outcomes:
measure: causes for hypomagnesemia
timeFrame: one year
measure: re-hospitalization
timeFrame: one year
measure: Subjective well-being
timeFrame: one year
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
affiliation: haemek medical center
name: Frieda Wolf
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.