Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia

Abstract

BackgroundSickle cell anemia (SCA) is the most common inherited hemoglobinopathy worldwide. Infection is a major cause of illness and death in children with SCA, especially in sub-Saharan Africa where an estimated 50–90% of affected children die before their fifth birthday. Interventions to reduce the incidence and severity of infections are needed urgently. A high proportion of adults and children with SCA are zinc-deficient, and zinc deficiency leads to impaired immunity and an increased risk of infection. Zinc supplementation has been shown to decrease the risk of infection in adolescents and adults, but there are no data on the effectiveness of zinc for prevention of infection in children <\u20095\u2009years of age with SCA.Methods/designThe study will be a randomized, placebo-controlled, double-blind clinical trial in which 250 Ugandan children 1.00–4.99\u2009years of age with SCA will receive daily zinc supplementation (10\u2009mg oral dispersible tablet) or identical placebo for 12\u2009months.DiscussionIf this trial shows a reduction in severe or invasive infection incidence, it would be the basis for a multi-site, multi-country 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.Trial registrationClinicaltrials.gov, NCT03528434. Registered on May 17, 2018Protocol Version: 1.0. Date: Dec 11, 2017Sponsor: Indiana University. Sponsor’s protocol identifier, 1712339562