PMID- 17691590
OWN - NLM
STAT- MEDLINE
DCOM- 20070911
LR  - 20151119
IS  - 0004-4172 (Print)
IS  - 0004-4172 (Linking)
VI  - 57
IP  - 6A
DP  - 2007
TI  - Food interaction of oral uptake of iron / a clinical trial using 59Fe.
PG  - 401-16
AB  - OBJECTIVES: 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. DESIGN: 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. RESULTS: 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. CONCLUSION: 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.
FAU - Lundqvist, Hans
AU  - Lundqvist H
AD  - Department of Biomedical Radiation Sciences, Uppsala University, Uppsala, Sweden. 
      Hans.Lundqvist@bms.uu.se
FAU - Sjoberg, Folke
AU  - Sjoberg F
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Arzneimittelforschung
JT  - Arzneimittel-Forschung
JID - 0372660
RN  - 0 (Ferric Compounds)
RN  - 0 (Hemoglobins)
RN  - 0 (Iron Radioisotopes)
RN  - 0 (Tea)
RN  - 0 (Transferrin)
RN  - E1UOL152H7 (Iron)
RN  - UM5219H89V (teferrol)
SB  - IM
MH  - Adult
MH  - Anemia, Iron-Deficiency/drug therapy
MH  - Beverages
MH  - *Citrus sinensis
MH  - Cross-Over Studies
MH  - Data Interpretation, Statistical
MH  - Erythrocytes/metabolism
MH  - Female
MH  - Ferric Compounds/*pharmacokinetics
MH  - *Food-Drug Interactions
MH  - Hemoglobins/metabolism
MH  - Humans
MH  - Iron/blood/*pharmacokinetics
MH  - Iron Radioisotopes
MH  - Male
MH  - *Tea
MH  - Transferrin/metabolism
EDAT- 2007/08/19 09:00
MHDA- 2007/09/12 09:00
CRDT- 2007/08/19 09:00
PHST- 2007/08/19 09:00 [pubmed]
PHST- 2007/09/12 09:00 [medline]
PHST- 2007/08/19 09:00 [entrez]
AID - 10.1055/s-0031-1296689 [doi]
PST - ppublish
SO  - Arzneimittelforschung. 2007;57(6A):401-16. doi: 10.1055/s-0031-1296689.