Status:
COMPLETED
Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya
Lead Sponsor:
Lucas Otieno Tina, MD MSc
Collaborating Sponsors:
GlaxoSmithKline
Strathmore University
Conditions:
Sickle Cell Disease
Zinc Deficiency
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03293641
Start Date
May 20 2016
End Date
January 19 2017
Last Update
September 26 2017
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