NCT02518659

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

June 26, 2015

Last Update Submit

August 5, 2015

Conditions

Hypomagnesemia, Intestinal, With Secondary HypocalcemiaDrug Induced Hypomagnesemia

Keywords

hypomagnesemiahypocalcemiainulinFOSPPIproton-pump inhibitors

Outcome Measures

Primary Outcomes (1)

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

    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.

    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.

Secondary Outcomes (7)

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

    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.

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

    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.

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

    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.

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

    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.

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

    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.

  • +2 more secondary outcomes

Study Arms (2)

Inulin

OTHER

Intervention by inulin, max 20gr per day

Dietary Supplement: Inulin

No Inulin

NO INTERVENTION

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

Interventions

InulinDIETARY_SUPPLEMENT

This is the Intervention

Also known as: Beneo Orafti Synergy1
Inulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic PPI use
  • Hypomagnesemia

You may not qualify if:

  • Uncontrolled diabetes
  • Irregular use of the inulin fibers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 22762246BACKGROUND

  • 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.

    PMID: 23756852BACKGROUND

  • 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.

    PMID: 12514257BACKGROUND

MeSH Terms

Conditions

Hypomagnesemia 1, IntestinalHypocalcemia

Interventions

Inulin

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • René Bindels, Professor

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2015

First Posted

August 10, 2015

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

August 10, 2015

Record last verified: 2015-08