Prevalence and Intervention of Hypomagnesemia in Users of Proton-pump Inhibitors

NCT ID: NCT02518659

Last Updated: 2015-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-06-30

Brief Summary

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.

Detailed 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.

Conditions

Hypomagnesemia, Intestinal, With Secondary Hypocalcemia; Drug Induced Hypomagnesemia

Study Design

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

Study Groups

Inulin

Intervention by inulin, max 20gr per day

Group Type: OTHER

Inulin

Intervention Type: DIETARY_SUPPLEMENT

This is the Intervention

No Inulin

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Inulin

This is the Intervention

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Beneo Orafti Synergy1

Eligibility Criteria

Inclusion Criteria

• Chronic PPI use
• Hypomagnesemia

Exclusion Criteria

• Uncontrolled diabetes
• Irregular use of the inulin fibers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joost Drenth

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

René Bindels, Professor

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

References

Hess MW, Hoenderop JG, Bindels RJ, Drenth JP. Systematic review: hypomagnesaemia induced by proton pump inhibition. Aliment Pharmacol Ther. 2012 Sep;36(5):405-13. doi: 10.1111/j.1365-2036.2012.05201.x. Epub 2012 Jul 4.

Reference Type: BACKGROUND

PMID: 22762246 (View on PubMed)

Lameris AL, Hess MW, van Kruijsbergen I, Hoenderop JG, Bindels RJ. Omeprazole enhances the colonic expression of the Mg(2+) transporter TRPM6. Pflugers Arch. 2013 Nov;465(11):1613-20. doi: 10.1007/s00424-013-1306-0. Epub 2013 Jun 12.

Reference Type: BACKGROUND

PMID: 23756852 (View on PubMed)

Coudray C, Demigne C, Rayssiguier Y. Effects of dietary fibers on magnesium absorption in animals and humans. J Nutr. 2003 Jan;133(1):1-4. doi: 10.1093/jn/133.1.1.

Reference Type: BACKGROUND

PMID: 12514257 (View on PubMed)

Other Identifiers

NL37289.091.11

Identifier Type: OTHER

Identifier Source: secondary_id

NL nr.: 47262.091.13

Identifier Type: -

Identifier Source: org_study_id