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[This corrects the article DOI: 10.3389/fnut.2023.1230061.].
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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. In Phase I, the frequency of gastrointestinal symptoms associated with FS was unaffected by dosing with MNP or weekly administration; but participants taking IHAT more frequently reported abdominal pain (27%, p < 0.008) and nausea (4%, p = 0.009) than those taking FS, while those taking ASP more frequently reported nausea (8%, p = 0.009). Surprisingly, only 9% of participants taking IHAT at 120 mg Fe/day (Phase II) reported abdominal pain and no other group reported that symptom. 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.
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Racial or ethnic minorities with leukemia who receive HLA-identical sibling hematopoietic stem cell transplants (HSCTs) are reported to have worse survival when compared with whites. Characteristics of US HSCT centers according to the proportion of ethnic minorities who undergo transplantation were compared to explore systematic differences among centers; the association with 100-day mortality was evaluated to determine whether center factors may explain the observed discrepant survival among ethnic minorities. One hundred sixteen US transplantation centers that performed HLA-identical sibling transplantations for leukemia were analyzed. We compared physician and health care provider staffing, transplantation unit procedure and resources, and medical center organization according to the volume procedure ratio of ethnic minorities who underwent transplantation and also according to the ratio of Hispanics who underwent transplantation. Centers that performed transplantation in a higher proportion of ethnic minorities were more likely to perform fewer transplantations per year, to have fewer devoted transplant beds, to be in an urban setting, to have a lower physician to patient volume ratio, and to follow up survivors 1 year after transplantation. Centers that performed transplantation in a higher proportion of Hispanics were more likely to perform fewer transplantations per year and to have fewer devoted transplantation beds, were less likely to perform outpatient transplantations, were more likely to be in an urban setting, and were less likely to have posttransplantation immunization protocols. Observed differences in center factors were not associated with 100-day mortality after adjustment for disease severity. Our results suggest that the inferior survival reported in ethnic minorities after HSCT may not be readily explained by center effects.