Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya

NCT03293641 | Completed

• 1 other identifier: KEMRI SSC 2925
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sickle Cell Disease; Zinc Deficiency; Infection

Keywords

Children, Sickle Cell Disease, Zinc

Outcome Measures

Primary Outcomes (1)

• Measurement of change in zinc levels from baseline at study conclusion.

  Zinc Levels in Plasma

  6 months

Secondary Outcomes (4)

• Number of malaria episodes among recipients of zinc versus controls diagnosed by RDT or Microscopy.

  6 months

• Number of episodes of bacterial infections among recipients of zinc versus controls diagnosed by culture.

  6 months

• Incidence of malnutrition among recipients of zinc versus controls diagnosed based on anthropometric measurements.

  6 months

• Occurrences of Adverse Events (AEs) during the 6 month follow-up period among recipients of zinc versus controls.

  6 months

Study Arms (2)

Zinc Sulfate Tablet

EXPERIMENTAL

Zinc Sulfate Tablet 10 mg, 3 times a week plus Standard of Care for 6 months

Dietary Supplement: Zinc Sulfate Tablets; Drug: Standard of Care

Control Arm

PLACEBO COMPARATOR

Standard of Care for 6 months

Drug: Standard of Care

Interventions

Zinc Sulfate Tablets DIETARY_SUPPLEMENT

Zinc Sulfate Tablets 3 times every 7 days for 6 months.

Also known as: Zincos

Zinc Sulfate Tablet

Standard of Care DRUG

Folic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months

Also known as: Folic Acid, Proguanil, Penicillin V, Hydroxyurea

Control Arm; Zinc Sulfate Tablet

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lucas Otieno Tina, MD MSc: lead
• GlaxoSmithKline: collaborator
• Strathmore University: collaborator

MeSH Terms

Conditions

Anemia, Sickle Cell; Infections

Interventions

Zinc Sulfate; Standard of Care; Folic Acid; Proguanil; Penicillin V; Hydroxyurea

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines; Organic Chemicals; Penicillins; beta-Lactams; Lactams; Amides; Urea

Study Officials

• Lucas O Tina, MD MSc

  KEMRI/CREATES, Strathmore University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: September 26, 2017
• Study Start: May 20, 2016
• Primary Completion: January 19, 2017
• Study Completion: January 19, 2017
• Last Updated: September 26, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share