A clinical investigation of an iron-poly (sorbitol-gluconic acid) complex, Ferastral, for the treatment of iron deficiency anaemia.
A clinical investigation of an iron-poly (sorbitol-gluconic acid) complex, Ferastral, for the treatment of iron deficiency anaemia has been performed. The study was designed to determine the dose schedule, efficacy and tolerance of the drug. Two dose intervals were used, 500 mg of iron once a week or every third day. The study comprised 26 adult patients. After single doses of 500 mg of Ferastral given every third day levels of iron and unsaturated iron binding capacity (UIBC) in serum were estimated. Maximum values of iron in serum after the first injection were reached after 24 hours in two patients. After the second injection there was a further increase in the iron concentration with maximum values after 24 to 48 hours. A decrease in UIBC was seen in all patients. Urinary excretion of iron was about 15%. Most of the excretion took place during the first 72 hours following the injection. The haemoglobin increase was more rapid in the group receiving 500 mg of iron every third day. The difference was statistically significant two to four weeks after commencing treatment. After five weeks the difference in haemoglobin increase was no longer statistically significant. After eight weeks the mean haemoglobin had reached 13.1 g/100 ml in the group treated once a week and 13.4 g/100 ml in the group treated every third day. The preparation was well tolerated by all patients treated. No local or general side effects were observed.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000747:Anemia, Hypochromic / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D004338:Drug Combinations; D004341:Drug Evaluation; D005260:Female; D005942:Gluconates / Q000008:administration & dosage / Q000627:therapeutic use; D006454:Hemoglobins / Q000096:biosynthesis; D006801:Humans; D007273:Injections, Intramuscular; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007668:Kidney / Q000187:drug effects; D008099:Liver / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D013012:Sorbitol / Q000008:administration & dosage / Q000627:therapeutic use
D004338:Drug Combinations; D005942:Gluconates; D006454:Hemoglobins; D013012:Sorbitol; D007501:Iron