Drug Induced Hypomagnesemia Clinical Trial
— PrivetOfficial title:
Inulin- a Potential Preventive Dietary Supplement Against PPI Induced Hypomagnesemia
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | June 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Chronic PPI use - Hypomagnesemia Exclusion Criteria: - Uncontrolled diabetes - Irregular use of the inulin fibers |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Radboud University |
Coudray C, Demigné C, Rayssiguier Y. Effects of dietary fibers on magnesium absorption in animals and humans. J Nutr. 2003 Jan;133(1):1-4. Review. — View 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. Review. Erratum in: Aliment Pharmacol Ther. 2012 Dec;36(11-12):1109. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No |
| Secondary | Cases and controls: Mean serum Ca2+ 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 Ca2+ 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 Ca2+ (in mmol/L) were performed at days 0, 14, 28,42 and 56. | No |
| Secondary | Cases only: 24-hrs urine Mg2+ excretion without inulin at days 27/28 | Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs. | 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. | No |
| Secondary | Cases only: 24-hrs urine Mg2+ excretion with inulin at days 41/42 | Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs. | 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. | No |
| Secondary | Cases only: 24-hrs urine Ca2+ excretion without inulin at days 27/28 | Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs. | 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. | No |
| Secondary | Cases only: 24-hrs urine Ca2+ excretion with Inulin at days 41/42 | Measured values for respective timepoint is denoted as a mean +/- SEM in mmol/24hrs. | 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. | No |
| Secondary | Cases and controls: General demographics of PPI users (Composite measure) | Demographical data, extracted from patient reports with relevant data such as age, sex, PPI-use and Duration and relevant comorbidities | at day 0 | No |
| Secondary | Cases and Controls: Genetic screen of polymorphisms in the TRPM6 gene | Small PCR and Sanger sequencing of exons 26+27 of the gene TRPM6 (Mg2+ channel) | DNA was extracted from blood, amplified and sequenced in average 2 months after bloodwithdrawal | No |