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Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya

NCT ID: NCT03293641

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-20

Study Completion Date

2017-01-19

Brief Summary

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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

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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.

Conditions

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Sickle Cell Disease Zinc Deficiency Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Zinc Sulfate Tablet

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

Group Type EXPERIMENTAL

Zinc Sulfate Tablets

Intervention Type DIETARY_SUPPLEMENT

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

Standard of Care

Intervention Type DRUG

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

Control Arm

Standard of Care for 6 months

Group Type PLACEBO_COMPARATOR

Standard of Care

Intervention Type DRUG

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

Interventions

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Zinc Sulfate Tablets

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

Intervention Type DIETARY_SUPPLEMENT

Standard of Care

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

Intervention Type DRUG

Other Intervention Names

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Zincos Folic Acid, Proguanil, Penicillin V, Hydroxyurea

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Strathmore University

OTHER

Sponsor Role collaborator

Lucas Otieno Tina, MD MSc

OTHER

Sponsor Role lead

Responsible Party

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Lucas Otieno Tina, MD MSc

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lucas O Tina, MD MSc

Role: PRINCIPAL_INVESTIGATOR

KEMRI/CREATES, Strathmore University

Other Identifiers

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KEMRI SSC 2925

Identifier Type: -

Identifier Source: org_study_id