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Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya

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ClinicalTrials.gov Identifier: NCT03293641
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Collaborators:
GlaxoSmithKline
Strathmore University
Information provided by (Responsible Party):
Lucas Otieno Tina, MD MSc, Kenya Medical Research Institute

Tracking Information
First Submitted Date  ICMJE April 14, 2017
First Posted Date  ICMJE September 26, 2017
Last Update Posted Date September 26, 2017
Actual Study Start Date  ICMJE May 20, 2016
Actual Primary Completion Date January 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
Measurement of change in zinc levels from baseline at study conclusion. [ Time Frame: 6 months ]
Zinc Levels in Plasma
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
  • Number of malaria episodes among recipients of zinc versus controls diagnosed by RDT or Microscopy. [ Time Frame: 6 months ]
    Malaria Incidence
  • Number of episodes of bacterial infections among recipients of zinc versus controls diagnosed by culture. [ Time Frame: 6 months ]
    Bacterial Infection Incidence
  • Incidence of malnutrition among recipients of zinc versus controls diagnosed based on anthropometric measurements. [ Time Frame: 6 months ]
    Anthropometric Measurements i.e. Weight, Height and Mid Upper Arm Circumference
  • Occurrences of Adverse Events (AEs) during the 6 month follow-up period among recipients of zinc versus controls. [ Time Frame: 6 months ]
    Adverse Events including Serious Adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya
Official Title  ICMJE The Effects of Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya: a Pilot Study
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Sickle Cell Disease
  • Zinc Deficiency
  • Infection
Intervention  ICMJE
  • Dietary Supplement: Zinc Sulfate Tablets
    Zinc Sulfate Tablets 3 times every 7 days for 6 months.
    Other Name: Zincos
  • Drug: Standard of Care
    Folic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months
    Other Name: Folic Acid, Proguanil, Penicillin V, Hydroxyurea
Study Arms  ICMJE
  • Experimental: Zinc Sulfate Tablet
    Zinc Sulfate Tablet 10 mg, 3 times a week plus Standard of Care for 6 months
    Interventions:
    • Dietary Supplement: Zinc Sulfate Tablets
    • Drug: Standard of Care
  • Placebo Comparator: Control Arm
    Standard of Care for 6 months
    Intervention: Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 19, 2017
Actual Primary Completion Date January 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03293641
Other Study ID Numbers  ICMJE KEMRI SSC 2925
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lucas Otieno Tina, MD MSc, Kenya Medical Research Institute
Study Sponsor  ICMJE Lucas Otieno Tina, MD MSc
Collaborators  ICMJE
  • GlaxoSmithKline
  • Strathmore University
Investigators  ICMJE
Principal Investigator: Lucas O Tina, MD MSc KEMRI/CREATES, Strathmore University
PRS Account Kenya Medical Research Institute
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP