Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya

• Status: Completed
• Trial end date: 2017-01-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lucas Otieno Tina, MD MSc
• Collaborators: GlaxoSmithKline; Strathmore University
• Treatments: Folic Acid; Hydroxyurea; Penicillin V; Penicillins; Proguanil; Zinc; Zinc Sulfate

Criteria

Inclusion Criteria:

• Male or female infants and children ≥ 6 months and < 13 years of age with confirmed SCD.

• Written informed consent obtained from the participant's parent/Legally Acceptable Representative (LAR).

• Available to participate for the study duration (approximately six months)

Exclusion Criteria:

• Written informed consent NOT obtained from the participant's parent/Legally Acceptable Representative (LAR).

• Profound clinical evidence of current immunosuppression or evidence of active AIDS defining illness i.e. WHO HIV clinical stage III/IV

• History of allergic reactions to zinc or any other ingredients in the supplement

• History of any neurologic disorders or seizures

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, as determined by physical examination or laboratory screening tests

• Hemoglobin ≤7.0 g/dL in children aged 6 months to ≤ 2 years.

• Hemoglobin ≤ 6 g/dL in children aged >2yrs to <13 years.

• Total White Cell Count below normal range <4.5 x 103/uL

• Use of any investigational or non-registered drugs or vaccines or planned use

• Simultaneous participation in any other clinical trial

• Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.