(P29-047-20) Ferrous Sulfate-Iron (60 mg/d) Does Not Increase Risks to Malarial Infectivity, Pathogenic Bacterial Proliferation or Other Adverse Effects in Non-Anemic Healthy Adults

Objectives: A double-blind, placebo-controlled, randomized clinical trial was conducted to determine the effects of different modalities of supplementation with ferrous sulfate (FeSO₄)-iron on the safety profiles of non-anemic, healthy adults.

Methods: Eligible volunteers (194) were screened for general health; 108 were enrolled and randomized to four treatment groups (n=27):  a placebo (corn starch), daily doses of FeSO₄ providing 60 mg Fe/d with or without a 15-component multiple micronutrient powder (UNICEF), or single weekly doses of FeSO₄ providing 420 mg Fe.  Treatment materials were provided in opaque capsules that were physically similar. The following safety profile indicators were assessed both before and after 28 days of intervention:  infectivity of subjects’ RBCs to Plasmodium falciparum determined ex vivo;  proliferation potential of 5 species of pathogenic bacteria (Escherichia coli, Acinetobacter baumannii, Klebsiella pneumonia, Staphylococcus aureus, and Salmonella typhimurium) in subjects’ sera determined ex vivo; markers of inflammation (fecal calprotectin; serum myeloperoxidase, alpha-1 antitrypsin and TNFα); parameters of iron status (serum Fe, Hb, transferrin, % transferrin saturation, and ferritin). Adverse events were assessed by the study physician.

Results: Results showed that no treatment affected: i) 28-day changes in either fasting or post-prandial levels of any parameter of Fe status; ii) 28-day changes in markers of gut or systemic inflammation; iii) RBC susceptibility to P. falciparum; iv) ex vivo proliferation of and bacterial species except A. baumannii, for which the 28-day change in post-prandial peak growth rate index was less than that of the placebo treatment group; or v) subject reported adverse events, which were minimal.

Conclusions: These results indicate that administration of FeSO₄ in these modalities to non-anemic, healthy adults are well tolerated and do not increase their risks to malarial infection and bacterial proliferation.

Funding Sources: The Bill and Melinda Gates Foundation
U.S. Department of Agriculture – Agricultural Research Service (ARS), under Agreement No. #58-1950-4-003