Protocol No: ECCT/15/06/02 Date of Protocol: 24-01-2015

Study Title:

The effects of Zinc supplementation in children with sickle cell disease in Western Kenya: a pilot study.

Study Objectives:
Laymans Summary:
Abstract of Study:

The proposed research project will evaluate the effects of zinc supplementation in children with sickle cell disease (SCD) in western Kenya. Zinc is a nutritionally essential trace element found in previous studies to reduce growth retardation and improve immune function, which may also result in decreased incidence of infectious diseases including malaria, pneumonia and diarrhea. SCD patients are known to be susceptible to zinc deficiency and appear to benefit from zinc supplementation. Despite these findings, SCD patients in Kenya have not benefited from zinc supplementation programmes? due to a lack of research and findings to inform policy in the East African-setting. Specifically, the proposed pilot research project will: investigate the influence of zinc supplementation on incidence of malaria infections in children with SCD; investigate the influence of zinc supplementation on incidence of bacterial infections (e.g. S pneumoniae, H influenzae and non-typhi Salmonella species) in children with SCD and investigate the influence of zinc supplementation on morbidity in children with SCD in western Kenya. We will conduct a 6 month randomized controlled pilot trial involving children with SCD aged 6 months to less than 13 years, being treated and followed up routinely at the KEMRI- site and other selected health facilities in Western Kenya for SCD. The children will be randomized into two arms, with the Intervention Group receiving the recommended Ministry of Health (MoH)/World Health Organization (WHO) standard care in addition to three times weekly zinc supplementation (10 mg) and the Control Group receiving standard MoH care alone over a six month period. At baseline, at 3 months and at 6 months, clinical and laboratory evaluations, including serum zinc levels, malaria blood slides, anthropometric measurements and other indicated laboratory tests will be conducted. In addition, HIV testing will be carried out during the study as an important confounder. The differences in incidence of morbidity and other secondary endpoints will be compared between the zinc group and the control group.  The results are expected to determine the scientific basis for a larger clinical trial to determine the need for the addition of zinc supplement to the management of sickle cell disease.