Zinc for Infection Prevention in Sickle cell anemia (ZIPS)
BACKGROUND: 75% of all children with sickle cell anemia (SCA) are born in sub-Saharan Africa, approximately 240,000 children annually. Infection is a major cause of illness and death in these children. Zinc deficiency leads to impaired immunity and an increased risk of infection, and a high proportion of adults and children with SCA are zinc deficient. Zinc supplementation has decreased infection in otherwise healthy children <5 years of age, and in adults and adolescents with SCA.
GAP: This study will define whether zinc supplementation can decrease incidence of severe or invasive infections in Ugandan children with SCA.
HYPOTHESIS: Zinc supplementation will lead to a lower incidence of severe or invasive infections than placebo in Ugandan children with SCA.
METHODS: The study will be a randomized, placebo-controlled, double blind clinical trial in which 250 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (10 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 12 months. The primary study outcome will be incidence of severe or invasive infections. Secondary outcomes will include incidence of all clinical infections, confirmed bacterial infections (by culture or PCR), incidence of VOC, change in height-for-age z-score, and incidence of zinc-related adverse events.
IMPACT: If this trial shows a reduction in severe or invasive infection incidence, it would be the basis for a multi-site pre-post intervention clinical trial to assess real-world safety and efficacy of zinc in African children with SCA. Since zinc is safe, inexpensive, and easy to administer, this trial has the potential to improve the health of hundreds of thousands of African children with SCA through reduction of infection-related morbidity and mortality.