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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

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Zinc Deficiency Infection Dietary Supplement: Zinc Sulfate Tablets Drug: Standard of Care Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Official Title: The Effects of Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya: a Pilot Study
Actual Study Start Date : May 20, 2016
Actual Primary Completion Date : January 19, 2017
Actual Study Completion Date : January 19, 2017


Arm Intervention/treatment
Experimental: Zinc Sulfate Tablet
Zinc Sulfate Tablet 10 mg, 3 times a week plus Standard of Care for 6 months
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

Placebo Comparator: Control Arm
Standard of Care for 6 months
Drug: Standard of Care
Folic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months
Other Name: Folic Acid, Proguanil, Penicillin V, Hydroxyurea




Primary Outcome Measures :
  1. Measurement of change in zinc levels from baseline at study conclusion. [ Time Frame: 6 months ]
    Zinc Levels in Plasma


Secondary Outcome Measures :
  1. Number of malaria episodes among recipients of zinc versus controls diagnosed by RDT or Microscopy. [ Time Frame: 6 months ]
    Malaria Incidence

  2. Number of episodes of bacterial infections among recipients of zinc versus controls diagnosed by culture. [ Time Frame: 6 months ]
    Bacterial Infection Incidence

  3. 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

  4. 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



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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293641


Sponsors and Collaborators
Lucas Otieno Tina, MD MSc
GlaxoSmithKline
Strathmore University
Investigators
Principal Investigator: Lucas O Tina, MD MSc KEMRI/CREATES, Strathmore University

Responsible Party: Lucas Otieno Tina, MD MSc, Principal Investigator, Kenya Medical Research Institute
ClinicalTrials.gov Identifier: NCT03293641     History of Changes
Other Study ID Numbers: KEMRI SSC 2925
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lucas Otieno Tina, MD MSc, Kenya Medical Research Institute:
Children, Sickle Cell Disease, Zinc

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Zinc
Folic Acid
Hydroxyurea
Penicillins
Penicillin V
Proguanil
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Vitamin B Complex
Vitamins
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Astringents
Dermatologic Agents