Tolerability of Oral Supplementation with Microencapsulated Ferric Saccharate Compared to Ferrous Sulphate in Healthy Premenopausal Woman: A Crossover, Randomized, Double-Blind Clinical Trial.

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 compared to MFS. The better tolerability profile of MFS over FS was further substantiated when both products were compared to a real-life setting (i.e., the washout period). Overall, the administration of both study products was safe with no serious or significant adverse events reported. In summary, the current study shows the better tolerability of the MFS preparation when compared to that of the FS, presenting MFS as a well-tolerated and safe option for improving iron nutrition.

Micronized, Microencapsulated Ferric Iron Supplementation in the Form of >Your< Iron Syrup Improves Hemoglobin and Ferritin Levels in Iron-Deficient Children: Double-Blind, Randomized Clinical Study of Efficacy and Safety.

A major problem of oral iron supplementation efficacy in children is its tolerability and compliance. We aimed to determine the safety and efficacy of a novel food supplement >Your< Iron Syrup in the replenishment of iron stores and improvement of hematological parameters in iron-deficient children aged nine months to six years. We randomized 94 healthy children with iron deficiency in a ratio of 3:1 to either receive >Your< Iron Syrup or placebo. A 12-week supplementation with >Your< Iron Syrup resulted in a significant increase in ferritin and hemoglobin levels as compared to placebo (p = 0.04 and p = 0.02). Adverse events were reported with similar frequencies across both study arms. >Your< Iron Syrup represents an effective, well-tolerated, and safe option for the management of nutritional iron deficiency in children.

Efficacy of a Novel Food Supplement (Ferfer®) Containing Microencapsulated Iron in Liposomal Form in Female Iron Deficiency Anemia.

Introduction Iron deficiency anemia (IDA) is a highly afflicting condition which affects young children of growing age and reproductive age women in countries of lower economies. Conventional oral iron salts have poor absorption and gastrointestinal side effects. Microencapsulated liposomal iron pyrophosphate is a novel compound with enhanced palatability, higher bioavailability, and consequently increased adherence among people with IDA. This study aims to assess the efficacy of microencapsulated iron pyrophosphate sachets in non-pregnant women with IDA. Methods It was a 12-week long, open label clinical trial conducted with 558 IDA women. Participants were advised one sachet of microencapsulated liposomal iron pyrophosphate (Ferfer®) twice daily. At baseline, and every four-week interval, serum hemoglobin levels and taste tolerability were assessed. Data was entered and analyzed using SPSS v. 24 (IBM Corp, Armonk, NY, USA). Results Four hundred and thirty-seven women completed the trial. The mean serum Hb level at baseline was 8.71 ± 2.24 which increased to 10.47 ± 1.69 by the end of 12 weeks (p < 0.001). Conclusion Treatment of IDA with microencapsulated liposomal iron pyrophosphate sachets significantly increases serum hemoglobin levels in non-pregnant women of reproductive age.

Bioavailability of Microencapsulated Iron from Fortified Bread Assessed Using Piglet Model.

The aim of this study was to investigate the influence of oral iron supplementation, in the form of fortified breads, on the growth performance, health, iron status parameters, and fecal metabolome of anemic piglets. A study was conducted on 24 hybrid (Large White × Landrace × Duroc) piglets. From day 44, the post-natal 12 piglets were supplemented with 100 g of one of two experimental breads, each fortified with 21 mg of ferrous sulphate, either encapsulated or not. After one week of oral supplementation, hematological parameters (hematocrit value, hemoglobin, and red blood cells) showed statistically significant differences (p ≤ 0.05). Piglets fed with the fortified breads had higher iron concentrations in the heart, liver, and intestinal mucosa compared to anemic piglets fed with control bread. Gene expression of hepcidin, iron exporter ferroportin (IREG1), and divalent metal transporter 1 (DMT1), together with concentrations of plasma ferritin, showed no significant statistical differences between groups. Both fortified breads could be used as sources of bioavailable iron. The seven-day intervention trial showed microencapsulation to have only a mild effect on the effectiveness of iron supplementation in the form of fortified bread.