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Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya

NCT03293641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-09-26

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Zinc Sulfate Tablets

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

DRUG

Standard of Care

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Strathmore University

    collaborator OTHER

  • Lucas Otieno Tina, MD MSc

    lead OTHER

Principal Investigators

  • Lucas O Tina, MD MSc · KEMRI/CREATES, Strathmore University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-20
Primary Completion
2017-01-19
Completion
2017-01-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03293641 on ClinicalTrials.gov