Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya
Condition: Sickle Cell Disease; Zinc Deficiency; Infection
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      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. Sickle Cell Disease (SCD)
      patients are known to be susceptible to zinc deficiency and appear to benefit from zinc
      supplementation. The proposed pilot research project aims to investigate the influence of
      zinc supplementation on incidence of malaria infections, incidence of bacterial infections
      and investigate the influence of zinc supplementation on morbidity in children with SCD in
      western Kenya. The differences in incidence of morbidity and other secondary endpoints will
      be compared between the zinc group and the control group.
    

Detailed description: 
      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 programs due to
      a lack of research and findings to inform policy in the East African-setting. The proposed
      pilot research project aims to 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. 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 will be enrolled. 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.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.
    

Intervention name(s): Zinc Sulfate Tablets; Standard of Care
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Zinc Sulfate Tablets 3 times every 7 days for 6 months.; Folic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months
Other intervention name(s): Zincos; Folic Acid, Proguanil, Penicillin V, Hydroxyurea
Intervention MeSH terms: Folic Acid; Penicillins; Penicillin V; Proguanil; Hydroxyurea; Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Pilot Trial in which children aged 6 months to less than 13 years were randomized on a ration of 1:1 to receive the Zinc plus Standard of Care versus Standard of Care Management for Sickle Cell Disease
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children, Sickle Cell Disease, Zinc