Food interaction of oral uptake of iron / a clinical trial using 59Fe

A primary objective of the study was to evaluate how food as well as a specific enhancer or an inhibitor of iron uptake affect erythrocyte iron uptake after oral administration of iron(III)-hydroxide polymaltose complex (IPC, Maltofer) in subjects with or without iron deficiency. Secondary objectives of the study were 1. to compare the uptake of 59Fe in erythrocytes between subjects with or without iron deficiency, 2. to evaluate the 59Fe activity in plasma after oral administration of IPC and 3. to evaluate the safety of oral administration of IPC by adverse events (AEs), vital signs, and hematological and clinical chemistry parameters.

Single-centre study with a crossover design. Each subject participated in two periods where single doses of 100 mg iron as IPC labeled with 59Fe were administered. In one period the subjects were fasting and in the other they were fed (Group A and Group B). Alternatively the study medication was administered in the fed state with an iron absorption enhancer (orange juice) or an iron absorption inhibitor (black tea, Group C and Group D). Eight subjects were included in each group, i.e. 32 subjects were included in total. All subjects completed the study and were included in the analyses of data.

In terms of relative incorporation of iron in erythrocytes, both subjects with and without iron deficiency benefited from the concomitant administration of an enhancer with the IPC. In iron deficiency subjects the iron uptake was improved when administered with food whereas for the normal subjects the uptake was greater during fasting conditions. The uptake of 59Fe in erythrocytes was greater in subjects with iron deficiency compared to the normal subjects, except when IPC was administered during fasting conditions. The safety assessments performed in this study did not demonstrate any unexpected observations or safety concerns with IPC.

In both subjects with and without iron deficiency treated with IPC the relative iron incorporation in erythrocytes increased in case of a concomitant administration of an enhancer. Furthermore, the 59Fe uptake in erythrocytes was higher in subjects with iron deficiency compared to normal subjects, except when IPC was administered during fasting conditions.