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Effects of oral iron and calcium supplement on the pharmacokinetics and pharmacodynamics of molidustat: an oral HIF-PH inhibitor for the treatment of renal anaemia.

Plain-language guide to PMID 31919558 (2020): open-label randomized controlled trial of Copper (Supplement) in 15 participants.

Key Facts

PMID
31919558
Journal
European journal of clinical pharmacology
Year
2020
Study type
Randomized Controlled Trial
Authors
Lentini S et al. (5 authors)
DOI
10.1007/s00228-019-02813-y

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of Copper (Supplement), published as a randomized controlled trial.

The present studies assessed the drug-drug interaction of molidustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, with iron and calcium supplements, which are common medications in patients with anaemia due to chronic kidney disease (CKD).

Who Took Part

The abstract describes 15 participants taking part.

The age groups tagged for this paper are young adults, adults and middle-aged adults, men only.

Forty-two healthy men received molidustat alone (fasted or fed) or combined with oral iron(II) or calcium(II), given immediately before or between 4 h before and 1 h after molidustat in three randomized, open-label, crossover studies (12-15 participants per study).

How the Study Was Run

The design is described as randomized, open-label and crossover.

Random assignment meant chance, not the researchers, decided who got Copper (Supplement) and who got the comparison, which limits bias.

Being open-label, the Copper (Supplement) study did not mask who received what.

In the crossover set-up each of the participants took both Copper (Supplement) and the comparison in turn, acting as their own control.

What Was Measured

Topics PubMed links to this paper include Anemia, Area Under Curve, Calcium, Dietary Supplements, Drug Interactions, Erythropoietin and Hypoxia-Inducible Factor-Proline Dioxygenases.

The authors tagged it with the keywords Drug—drug interaction, Molidustat and Oral iron and calcium supplementation.

What This Means in Plain Language

The paper is a randomized, open-label and crossover study of Copper (Supplement) in 15 participants.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2020 (European journal of clinical pharmacology), a journal based in Germany.

More context: the Copper (Supplement) compound page, all human trials.

Our Notes on the Compound

Copper (Supplement): The active site of cytochrome c oxidase is described as containing copper ions that are essential for electron transfer.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.