Drug Induced Hypomagnesemia Clinical Trial
Official title:
Inulin- a Potential Preventive Dietary Supplement Against PPI Induced Hypomagnesemia
Hypomagnesemia is a severe side effect of longterm use of all available proton-pump
inhibitors (PPIH). It develops due to intestinal malabsorption of Mg2+.
This study investigates the application of dietary inulin fibers in users of proton-pump
inhibitors with such a hypomagnesemia. To this end, repetitive short-term trials of 14 days
of orally administered inulin, separated by a wash-out period of 14 days each were performed
in cases of PPIH and controls. This study was not blinded or randomized.
Hypomagnesemia due to PPI use (PPIH) has a low frequency, but is a difficult to control side
effect in clinical practice. It develops over years and results in severe symptoms related
to the hypomagnesemia. Due to the widespread use of PPIs, the real number of PPIH may be
high. Currently, there is a lack of intervention strategies and no general treatment
protocols for patients exist. It is generally anticipated that PPI-withdrawal and antacid
replacement therapy is the only working method to recover patients from the hypomagnesemia.
However, this frequently resulted in rebound of gastric acid related complaints.
The molecular mechanism of PPIH involves a reduction of Mg2+ absorption by the large
intestine. Inulin fibers have been shown to have prebiotic properties. The intestinal
microbiome ferments inulin and releases butyrate into the luminal compartment of the
intestine. This results in acidification which enhances the uptake of Mg2+ and Ca2+ mediated
by pH-sensitive ionchannels.Thus inulin may counteract PPI induced reduction of luminal
protons and therefore reestablish normal Mg2+ absorption.
To this end cases with PPIH and controls underwent two 14 day trials of orally administered
inulin under separated by wash-out periods of 14 days. During the experimental phase blood
measures of electrolytes were monitored.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment