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

Authors

Dibyadyuti Datta, Indiana University School of Medicine, USA
Ruth Namazzi, Makerere University, Uganda
Andrea L. Conroy, Indiana University School of Medicine, USA
Sarah E. Cusick, University of Minnesota School of Medicine, USA
Heather A. Hume, University of Montreal, Canada
Abner Tagoola, Jinja Regional Referral Hospital, Uganda
Russell E. Ware, Cincinnati Children’s Hospital, USA
Robert Opoka, Aga Khan UniversityFollow
Chandy C. John, Indiana University School of Medicine, USA

Document Type

Article

Department

Paediatrics and Child Health (East Africa)

Abstract

Background:

Sickle 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 < 5 years of age with SCA.

Methods/design:

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 daily zinc supplementation (10 mg oral dispersible tablet) or identical placebo for 12 months.

Discussion: If 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.

Comments

This work was published before the author joined Aga Khan University.

Publication (Name of Journal)

Trials

DOI

10.1186/s13063-019-3569-z

Recommended Citation

Datta, D., Namazzi, R., Conroy, A. L., Cusick, S. E., Hume, H. A., Tagoola, A., Ware, R. E., Opoka, R., John, C. C. (2019). Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia. Trials, 20(460), 1-11.
Available at: https://ecommons.aku.edu/eastafrica_fhs_mc_paediatr_child_health/471

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.