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RCT·clinical trial, nutrition, micronutrients, minerals, internal medicine·PMC10603204

Safe and effective delivery of supplemental iron to healthy adults: a two-phase, randomized, double-blind trial – the safe iron study

Frontiers in Nutrition · 22 authors, 5 centres

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TL;DR

This two-phase randomized, double-blind trial compared the safety of three iron forms (IHAT, ASP, ferrous sulphate) in healthy, iron-replete adults.

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690 CHARS

This study was a two-phase, randomized, double-blind, placebo-controlled trial conducted in Boston to assess the safety of two novel iron forms (IHAT and ASP) compared to ferrous sulphate (FS) in healthy, iron-replete adults. The primary outcomes, for which the study was powered, were ex vivo susceptibility of erythrocytes to Plasmodium falciparum infection, proliferation potential of selected pathogenic bacteria, and fecal calprotectin as a marker of gut inflammation. The study found that supplementation with any form of iron did not affect any primary endpoint. The results suggest that 28 days of IHAT or ASP supplementation at these doses may be as safe as FS for this population.

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RCT

SPECIALTY

clinical trial

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ORIGINAL PAPER

PMC10603204

Safe and effective delivery of supplemental iron to healthy adults: a two-phase, randomized, double-blind trial – the safe iron study

Frontiers in Nutrition

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ABSTRACT

Abstract Introduction The safety of novel forms of iron in healthy, iron-replete adults as might occur if used in population-based iron supplementation programs was examined. We tested the hypotheses that supplementation with nanoparticulate iron hydroxide adipate tartrate (IHAT), an iron-enriched Aspergillus oryzae product (ASP), or ferrous sulphate heptahydrate (FS) are safe as indicated by erythrocyte susceptibility to malarial infection, bacterial proliferation, and gut inflammation. Responses to FS administered daily or weekly, and with or without other micronutrients were compared. Methods Two phases of randomized, double-blinded trials were conducted in Boston, MA. Phase I randomized 160 volunteers to six treatments: placebo, IHAT, ASP, FS, and FS plus a micronutrient powder (MNP) administrated daily at 60 mg Fe/day; and FS administered as a single weekly dose of 420 mg Fe. Phase II randomized 86 volunteers to IHAT, ASP, or FS administered at 120 mg Fe/day. Completing these phases were 151 and 77 participants, respectively. The study was powered to detect effects on primary endpoints: susceptibility of participant erythrocytes to infection by Plasmodium falciparum , the proliferation potential of selected pathogenic bacteria in sera, and markers of gut inflammation. Secondary endpoints for which the study was not powered included indicators of iron status and gastrointestinal symptoms. Results Supplementation with any form of iron did not affect any primary endpoint. Regarding secondary endpoints, in Phase I participants taking IHAT more frequently reported abdominal pain (27%, p = 0.008) than other iron forms; those taking the weekly FS dose more frequently reported nausea (20%, p = 0.009) than the other forms and modes of administration. In phase II, no such differences were observed. Discussion With respect to the primary endpoints, few differences were found when comparing these forms of iron, indicating that 28 days of 60 or 120 mg/day of IHAT, ASP, or FS may be safe for healthy, iron-replete adults. With respect to other endpoints, subjects receiving IHAT more frequently reported abdominal pain and nausea, suggesting the need for further study. Clinical Trial Registration ClinicalTrials.gov , NCT03212677 ; registered: 11 July 2017. Keywords: iron, ferrous sulfate, malarial infectivity, bacterial proliferation, gut inflammation, IHAT, fungal iron

CITATION EXPORT

Erin D Lewis, Edwin F Ortega, Maria Carlota Dao et al.. Safe and effective delivery of supplemental iron to healthy adults: a two-phase, randomized, double-blind trial – the safe iron study. Frontiers in Nutrition. (2023). https://doi.org/10.3389/fnut.2023.1230061

AUTHORS

22 · 5 CENTRES

Erin D Lewis, Edwin F Ortega, Maria Carlota Dao, Kathryn Barger, Joel B Mason, John M Leong, Marcia S Osburne, Loranne Magoun, Felix J Nepveux V, Athar H Chishti, Christopher Schwake, Anh Quynh, Cheryl H Gilhooly, Gayle Petty, Weimin Guo, Gregory Matuszek, Dora Pereira, Manju Reddy, Jifan Wang, Dayong Wu, Simin N Meydani, Gerald F Combs

1Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, United States
2Department of Molecular Biology and Microbiology, Tufts University, Boston, MA, United States
3Department of Developmental, Molecular and Chemical Biology, Tufts University, Boston, MA, United States
4Department of Pathology, University of Cambridge, Cambridge, United Kingdom
5Department of Food Science and Human Nutrition, Iowa State University, Ames, IA, United States