Tolerability of Oral Supplementation with Microencapsulated Ferric Saccharate Compared to Ferrous Sulphate in Healthy Premenopausal Woman: A Crossover, Randomized, Double-Blind Clinical Trial
Author/s
Friling, Marina; García Muñoz, Ana María; Perrinjaquet Moccetti, Tania; Victoria Montesinos, Desirée; Pérez Piñero, Desirée; [et al.]Date
2022-10-14Discipline/s
Ciencias de la AlimentaciónSubject/s
Iron supplementationAB-Fortis®
Microencapsulated iron
Ferric saccharate
Ferrous sulphate
Gastrointestinal side effects
Tolerability
Abstract
A single-center, crossover, randomized, double-blind, and controlled clinical study was conducted to assess the tolerability profile, especially with regard to gastrointestinal complaints, of oral supplementation with AB-Fortis®, a microencapsulated ferric saccharate (MFS), as compared with conventional ferrous sulphate (FS) in healthy premenopausal women. A dose of 60 mg/day of elemental iron was used. The test products were administered for 14 consecutive days with a washout period of two menstrual episodes and a minimum of one month between the two intervention periods. The subjects completed simple-to-answer questionnaires daily for 14 days during both the intervention and the washout periods, capturing the symptoms associated with oral iron supplementation and overall health aspects. Following product consumption, the incidences of symptoms, numbers of complaints/symptoms, overall intensity, and total days with symptoms were found to be significantly higher for FS consumption as c...