A randomized, double-blind clinical study on the safety and tolerability of an iron multi-amino acid chelate preparation in premenopausal women

J Diet Suppl. 2013 Mar;10(1):17-28. doi: 10.3109/19390211.2012.758217. Epub 2013 Feb 7.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Amino Acids / therapeutic use*
  • Anemia, Iron-Deficiency / prevention & control*
  • Double-Blind Method
  • Female
  • Ferrous Compounds / adverse effects
  • Ferrous Compounds / therapeutic use
  • Hematologic Tests
  • Humans
  • Iron / therapeutic use*
  • Iron Chelating Agents / therapeutic use*
  • Iron Compounds / adverse effects*
  • Iron Compounds / therapeutic use
  • Premenopause
  • Treatment Outcome

Substances

  • Amino Acids
  • Ferrous Compounds
  • Iron Chelating Agents
  • Iron Compounds
  • ferrous sulfate
  • Iron