Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-24 @ 3:48 PM
Study NCT ID:
NCT02518659
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2015-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Intervention of Hypomagnesemia in Users of Proton-pump Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C566593', 'term': 'Hypomagnesemia 1, Intestinal'}, {'id': 'D006996', 'term': 'Hypocalcemia'}], 'ancestors': [{'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007444', 'term': 'Inulin'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005630', 'term': 'Fructans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2015-06-26', 'studyFirstSubmitQcDate': '2015-08-05', 'lastUpdatePostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cases and controls: Mean serum Mg2+ treatment effect of inulin (composite measure)', 'timeFrame': '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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cases and controls: Mean serum Ca2+ treatment effect of inulin (composite measure)', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Cases only: 24-hrs urine Mg2+ excretion without inulin at days 27/28', 'timeFrame': '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.', 'description': 'Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs.'}, {'measure': 'Cases only: 24-hrs urine Mg2+ excretion with inulin at days 41/42', 'timeFrame': '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.', 'description': 'Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs.'}, {'measure': 'Cases only: 24-hrs urine Ca2+ excretion without inulin at days 27/28', 'timeFrame': '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.', 'description': 'Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs.'}, {'measure': 'Cases only: 24-hrs urine Ca2+ excretion with Inulin at days 41/42', 'timeFrame': '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.', 'description': 'Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs.'}, {'measure': 'Cases and controls: General demographics of PPI users (Composite measure)', 'timeFrame': 'at day 0', 'description': 'Demographical data, extracted from patient reports with relevant data such as age, sex, PPI-use and Duration and relevant comorbidities'}, {'measure': 'Cases and Controls: Genetic screen of polymorphisms in the TRPM6 gene', 'timeFrame': 'DNA was extracted from blood, amplified and sequenced in average 2 months after bloodwithdrawal', 'description': 'Small PCR and Sanger sequencing of exons 26+27 of the gene TRPM6 (Mg2+ channel)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypomagnesemia', 'hypocalcemia', 'inulin', 'FOS', 'PPI', 'proton-pump inhibitors'], 'conditions': ['Hypomagnesemia, Intestinal, With Secondary Hypocalcemia', 'Drug Induced Hypomagnesemia']}, 'referencesModule': {'references': [{'pmid': '22762246', 'type': 'BACKGROUND', 'citation': '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': '23756852', 'type': 'BACKGROUND', 'citation': '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': '12514257', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Hypomagnesemia is a severe side effect of longterm use of all available proton-pump inhibitors (PPIH). It develops due to intestinal malabsorption of Mg2+.\n\nThis 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.', 'detailedDescription': '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.\n\nThe 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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic PPI use\n* Hypomagnesemia\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Irregular use of the inulin fibers'}, 'identificationModule': {'nctId': 'NCT02518659', 'acronym': 'Privet', 'briefTitle': 'Prevalence and Intervention of Hypomagnesemia in Users of Proton-pump Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Inulin- a Potential Preventive Dietary Supplement Against PPI Induced Hypomagnesemia', 'orgStudyIdInfo': {'id': 'NL nr.: 47262.091.13'}, 'secondaryIdInfos': [{'id': 'NL37289.091.11', 'type': 'OTHER', 'domain': '2011/272'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Inulin', 'description': 'Intervention by inulin, max 20gr per day', 'interventionNames': ['Dietary Supplement: Inulin']}, {'type': 'NO_INTERVENTION', 'label': 'No Inulin', 'description': 'Same Patients of arm inulin. Here the phase without inulin supplementation (own controls)'}], 'interventions': [{'name': 'Inulin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beneo Orafti Synergy1'], 'description': 'This is the Intervention', 'armGroupLabels': ['Inulin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'René Bindels, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joost Drenth', 'investigatorAffiliation': 'Radboud University Medical Center'}}}}