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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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OBJECTIVE: To assess, through an integrated primary and specialty care pediatric health system, the association of well-child checks prior to referral with final urological diagnosis with the aim to identify opportunities for earlier referral of care. METHODS: We performed a retrospective review of children referred from primary care to urology for undescended testis (UDT) within our integrated primary-specialty care health system in 2019, comparing children who had undescended testicles to those with either normal or retractile testicles based on the final urology examination. Demographics, including age, comorbidities, and the status of prior well-child check (WCC) within primary care, were reviewed. Outcomes of age at referral and surgical intervention for UDT were compared across referral categories. RESULTS: Stratifying by final diagnosis of 88 children included in the analysis, children with UDT were referred much later (85months, interquartile ranges 31-113) than children without UDT on final diagnosis (33months, interquartile ranges 15-74, P = .002). Furthermore, children with UDTs had a greater proportion with prior abnormal WCCs (N = 21/41, 51%) than those without UDT (N = 8/47, 17%) (P < .001). CONCLUSION: Children with prior abnormal WCCs were more likely to have a final diagnosis of UDT, with prior abnormalities being documented approximately 12months prior to referral, indicating opportunities for improved referral patterns to urology.