Daily zinc supplementation does not reduce the incidence of severe/invasive infections in children 5 years of age or younger with sickle cell disease (SCD), according to a study published in Blood Advances. The authors of the study sought to assess if zinc supplementation would decrease the incidence of severe/invasive infections in patients with SCD and related adverse events.
The research team conducted a randomized, double-blind, placebo-controlled trial between March 2019 and December 2020 among Ugandan children with SCD (ClinicalTrials.gov Identifier: NCT03528434). In addition to standard SCD maintenance care, which included folic acid supplementation, penicillin prophylaxis, malaria protection/prophylaxis, and hydroxyurea in cases of painful crises, participants were randomly assigned to receive either oral dispersive zinc sulfate tablets 10 mg daily or identical placebo tablets for 12 months. Follow-up visits were scheduled at 3-month intervals, during which participants were measured for their height and weight, assessed for treatment adherence, and evaluated for adverse events.
Parents of participants were asked to bring their children to the Nalufenya Sickle Cell Clinic for any illnesses. If the children presented with a temperature of ≥37.5°C, the possibility of malaria was assessed; if they presented with a temperature of ≥38°C, blood cultures were taken to investigate the possibility of severe/invasive infection.
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A total of 252 children were enrolled, with 2 later removed from the study for meeting the exclusion criteria; 250 patients were randomly assigned to receive zinc (n=124) or placebo (n=126). Treatment adherence in both cohorts was high (97.2% for those receiving zinc and 97.0% for those receiving placebo).
In terms of adverse events, the frequency of vomiting and nausea were similarly low across both groups. At the start of the study, 3 children were receiving hydroxyurea; this figure expanded to 117 during the trial. There was no significant difference in terms of the proportion of children on hydroxyurea therapy between both arms of the study.
In terms of severe/invasive infections (such as sepsis, malaria, gastroenteritis, and pharyngitis/tonsillitis), 105 (84.7%) children in the zinc arm had recorded infections; in the placebo arm, there were 100 children with infections (80.7%). There was no significant difference in the incidence of severe/invasive infections among children of both cohorts.
“In conclusion, the administration of daily oral zinc given at a standard dose of 10 mg did not reduce the incidence of severe or invasive infections in children <5 years of age with [SCD] in the context of a high prevalence of zinc deficiency and high infection burden,” the authors of the study noted in their report.
Disclosure: This research was supported by a grant from the Thrasher Research Fund (grand number: 20170925). Please see the original reference for a full list of disclosures.
Reference
Namazzi R, Opoka R, Conroy AL, et al. Zinc for infection prevention in children with sickle cell anemia: a randomized double-blind placebo-controlled trial. Blood Advances. Published online June 30, 2023. doi:10.1182/bloodadvances.2022008539
