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Safety and tolerability of iron amino acid chelate in premenopausal women
Author(s) -
Fouad Gameil T.,
Evans Malkanthi,
Barss Sonya,
Baisley Josh,
Crowley David,
Guthrie Najla
Publication year - 2008
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.22.2_supplement.746
Subject(s) - tolerability , ferrous , chemistry , chelation , creatinine , placebo , blood urea nitrogen , medicine , adverse effect , nuclear chemistry , inorganic chemistry , organic chemistry , pathology , alternative medicine
The objective of this study was to examine the safety and tolerability of an iron amino acid chelate 10% preparation (Ferroplex™, Biotron Laboratories, Inc., Centerville, Utah) in pre‐menopausal women. The design was a single‐center, randomized, double‐blind, three‐arm placebo‐controlled (n=60) study conducted in London, ON, Canada. Subjects were assigned to receive one of three test materials: iron amino acid chelate 10% or ferrous sulfate (600 mg capsules, each containing 25mg of elemental iron), or placebo and reported side effects/symptoms for a 7‐day period. Following supplementation, blood (fasting) was sampled for determination of complete blood count, platelets, electrolytes, glucose, blood urea nitrogen, creatinine, liver function tests, total protein and iron levels including iron ferritin, total iron binding capacity and erythrocyte protoporphyrin. The current study demonstrated the superiority of the iron amino acid chelate preparation ( Ferroplex™ ) with regard to tolerability and adverse effects compared to the ferrous sulphate preparation. The iron amino acid chelate ( Ferroplex™ ) studied was found to have significantly lower (P<0.05) adverse effects when compared to the ferrous sulphate preparation. There were no significant differences between the test products on any of the blood parameters measured. This study was sponsored by Biotron Laboratories, Inc.