Prevalence and Intervention of Hypomagnesemia in Users of Proton-pump Inhibitors (Privet)

Radboud University Medical Center

Status: Completed

Conditions: Drug Induced Hypomagnesemia; Hypomagnesemia, Intestinal, With Secondary Hypocalcemia

Treatments: Dietary Supplement: Inulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02518659

NL37289.091.11 (Other Identifier)

NL nr.: 47262.091.13

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Chronic PPI use
• Hypomagnesemia

Exclusion criteria

• Uncontrolled diabetes
• Irregular use of the inulin fibers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Inulin

Other group

Description:

Intervention by inulin, max 20gr per day

Treatment:

Dietary Supplement: Inulin

No Inulin

No Intervention group

Description:

Same Patients of arm inulin. Here the phase without inulin supplementation (own controls)