A Randomized, Double-Blind Clinical Study on the Safety and Tolerability of an Iron Multi-Amino Acid Chelate Preparation in Premenopausal Women. (8th February 2013)

• Record Type: Journal Article
• Authors: Fouad, Gameil T.; Evans, Malkanthi; Sharma, Prachi; Baisley, Joshua; Crowley, David; Guthrie, Najla
• Is Part Of: Journal of dietary supplements. Volume 10:Number 1(2013:Mar.)
• Page Start: 17
• Page End: 28
• Publication Date: 2013-02-08
• Subjects: Dietary supplements -- Periodicals; Dietary Supplements -- Periodicals; 613.205
• DOI: 10.3109/19390211.2012.758217
• Languages: English
• ISSNs: 1939-0211

Abstract

<abstract> <title>ABSTRACT</title> <p>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 (<italic>n</italic> = 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 (<italic>p</italic> = .044) higher number of patients reported adverse events when taking the ferrous sulfate supplement compared to IMAAC. A significantly lower number of adverse effects (<italic>p</italic> = .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.</p> </abstract>