title: A randomized, double-blind clinical study on the safety and tolerability of an iron multi-amino acid chelate preparation in premenopausal women.
abstract: ABSTRACT Considerable risk of iron deficiency has been identified in premenopausal women because of the adverse effects associated with commercial iron preparations. This study examined the safety and tolerability of a novel iron multi-amino acid chelate (IMAAC) preparation in premenopausal women. A single-centre, randomized, double-blind, three-arm placebo-controlled (n = 60) study was conducted where subjects received one of three test materials: IMAAC (600 mg) or ferrous sulfate (600 mg) each containing 25 mg of elemental iron, or placebo as a single daily dose for 7 days. After testing, there were no significant differences found in any of the hematological outcomes between the different test groups. The safety analyses showed that a significantly (p = .044) higher number of patients reported adverse events when taking the ferrous sulfate supplement compared to IMAAC. A significantly lower number of adverse effects (p = .008) were reported by subjects on IMAAC. The current study demonstrated the superiority of the IMAAC preparation over ferrous sulfate with regards to tolerability and adverse effects.
authors: Biotron Laboratories, Inc., Centerville, UT, USA.
authors: Gameil T
authors: GT
authors: Fouad
authors: Malkanthi
authors: M
authors: Evans
authors: Prachi
authors: P
authors: Sharma
authors: Joshua
authors: J
authors: Baisley
authors: David
authors: D
authors: Crowley
authors: Najla
authors: N
authors: Guthrie
mesh_terms: D000328:Adult; D000596:Amino Acids / Q000627:therapeutic use*; D018798:Anemia, Iron-Deficiency / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005296:Ferrous Compounds / Q000009:adverse effects / Q000627:therapeutic use; D006403:Hematologic Tests; D006801:Humans; D007501:Iron / Q000627:therapeutic use*; D007502:Iron Chelating Agents / Q000627:therapeutic use*; D058085:Iron Compounds / Q000009:adverse effects* / Q000627:therapeutic use; D017697:Premenopause; D016896:Treatment Outcome
chemical_list: D000596:Amino Acids; D005296:Ferrous Compounds; D007502:Iron Chelating Agents; D058085:Iron Compounds; C020748:ferrous sulfate; D007501:Iron