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Completed

NCT Number: NCT02518659

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

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.

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Key information

Conditions

Hypomagnesemia, Intestinal, With Secondary Hypocalcemia Calcium Metabolism Disorders Drug Induced Hypomagnesemia Hypocalcemia Hypomagnesemia 1, Intestinal Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic PPI use
  • Hypomagnesemia

Exclusion criteria

  • Uncontrolled diabetes
  • Irregular use of the inulin fibers

Treatment and study plan

Inulin

Dietary Supplement

This is the Intervention

Other names: Beneo Orafti Synergy1

Primary outcomes

  1. Cases and controls: Mean serum Mg2+ treatment effect of inulin (composite measure)

    Time frame: Cases and controls were followed for 56 days. Single measures of serum Mg2+ (in mmol/L) were performed at days 0, 14, 28,42 and 56.

    Measured values at respective timepoints are denoted as means +/- SEM in mmol/L. The treatment effect is calculated by the overall mean change of serum Mg2+ during the two inulin treated phases (Days 0 - 14 and days 28 - 42) and expressed as mean +/- SEM.

Secondary outcomes

  1. Cases and controls: Mean serum Ca2+ treatment effect of inulin (composite measure)

    Time frame: Cases and controls were followed for 56 days. Single measures of serum Ca2+ (in mmol/L) were performed at days 0, 14, 28,42 and 56.

    Measured values at respective timepoints are denoted as means +/- SEM in mmol/L. The treatment effect is calculated by the overall mean change of serum Ca2+ during the two inulin treated phases (Days 0 - 14 and days 28 - 42) and expressed as mean +/- SEM.

  2. Cases only: 24-hrs urine Mg2+ excretion without inulin at days 27/28

    Time frame: Collected 24-hrs urine samples are taken from each case at days 27/28. Samples were stored and measured within one week after day 56, the finalizing day of the respective participant.

    Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs.

  3. Cases only: 24-hrs urine Mg2+ excretion with inulin at days 41/42

    Time frame: Collected 24-hrs urine samples are taken from each case at days 41/42. Samples were stored and measured within one week after day 56, the finalizing day of the respective participant.

    Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs.

  4. Cases only: 24-hrs urine Ca2+ excretion without inulin at days 27/28

    Time frame: Collected 24-hrs urine samples are taken from each case at days 27/28. Samples were stored and measured within one week after day 56, the finalizing day of the respective participant.

    Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs.

  5. Cases only: 24-hrs urine Ca2+ excretion with Inulin at days 41/42

    Time frame: Collected 24-hrs urine samples are taken from each case at days 41/42. Samples were stored and measured within one week after day 56, the finalizing day of the respective participant.

    Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs.

  6. Cases and controls: General demographics of PPI users (Composite measure)

    Time frame: at day 0

    Demographical data, extracted from patient reports with relevant data such as age, sex, PPI-use and Duration and relevant comorbidities

  7. Cases and Controls: Genetic screen of polymorphisms in the TRPM6 gene

    Time frame: DNA was extracted from blood, amplified and sequenced in average 2 months after bloodwithdrawal

    Small PCR and Sanger sequencing of exons 26+27 of the gene TRPM6 (Mg2+ channel)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Inulin- a Potential Preventive Dietary Supplement Against PPI Induced Hypomagnesemia

Acronym: Privet

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 10, 2015
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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