[Effect of treatment with a food supplement (containing: selected sea fish cartilage, vitamin C, vitamin E, folic acid, zinc, copper) in women with iron deficiency: double blind, randomized, placebo-controlled trial].
OBJECTIVE
The term iron deficiency is used to indicate a condition in which the content of iron (Fe) in the organism is low, even before the consequent reduction in erythropoiesis comes about. This clinical situation is very frequent in patients in fertile age. The therapy commonly used (Fe salts) is often poorly tolerated. The use of a food supplement containing nutrients useful for improving the bioavailability of Fe and that is well tolerated can represent a valid alternative to iron therapy.


METHODS
The present study examines 49 fertile women with iron deficiency, of normal weight and not undergoing estroprogestin treatment. The patients underwent 3 assessments: basal, after 30 and after 60 days to determine their complete haemochrome, blood iron, blood ferritin, blood transferrin, iron binding capacity, folates, TSH, FT3, and FT4. Following the basal assessment, patients were randomly assigned to 1 of 2 treatment groups: treatment A (25 patients): food supplement containing hydrolyzed sea fish cartilage, vitamin C, vitamin E, folic acid, zinc, copper (Captafer); treatment B (24 patients): placebo.


RESULTS
The patients were then subdivided into 2 groups according to the basal blood iron (<60 microg/dL) or blood ferritin (<20 ng/mL) values. In the group presenting blood iron of <60 microg/dL only treatment A supplement produced a significant improvement in blood iron after 30 (P<0.001) and after 60 (P<0.005) days of treatment. The group with basal blood ferritin of <20 ng/mL presented blood iron levels of >60 microg/dL; in these patients after 60 days of treatment with the supplement, there was a significant increase in blood ferritin (P<0.05); the patients treated with placebo, on the other hand, did not show any significant difference compared to basal values.


CONCLUSIONS
This study has shown that, in patients with iron deficiency, the use of a food supplement, consisting of nutrients that improve the bioavailability of Fe, leads to a significant improvement in blood iron and blood ferritin levels.
Rondanelli
M
M
Unità Endocrino-Nutrizionale, Azienda Servizi alla Persona, Istituzioni Assistenziali Riunite di Pavia, Pavia, Italy. nutrizione.iar@virgilio.it
Opizzi
A
A
Andreoni
L
L
Trotti
R
R
D000328:Adult; D000818:Animals; D001205:Ascorbic Acid / Q000008:administration & dosage; D002356:Cartilage; D003300:Copper / Q000008:administration & dosage; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005399:Fishes; D005492:Folic Acid / Q000008:administration & dosage; D006801:Humans; D007501:Iron / Q000097:blood; D000090463:Iron Deficiencies; D014810:Vitamin E / Q000008:administration & dosage; D017967:Zinc Compounds / Q000008:administration & dosage
D017967:Zinc Compounds; D014810:Vitamin E; D003300:Copper; D005492:Folic Acid; D007501:Iron; D001205:Ascorbic Acid