Sickle Cell DiseaseNCT03293641
Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya
A study testing Zinc Sulfate Tablets in people with Sickle Cell Disease and Zinc Deficiency, run by Lucas Otieno Tina, MD MSc.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Sickle Cell Disease, Zinc Deficiency, Infection
- What is being tested?
- Zinc Sulfate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2016to 19 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 11Show fewer
- 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.
About this study
Official title: The Effects of Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya: a Pilot Study
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.
Read the 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.
- Conditions
- Sickle Cell Disease, Zinc Deficiency, Infection
- Being tested
- Zinc Sulfate Tablets, Standard of Care
- Keywords
- Children, Sickle Cell Disease, Zinc
- Medical subject headings
- Anemia, Sickle Cell, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Sulfate TabletsDietary supplement
Also called Zincos
Zinc Sulfate Tablets 3 times every 7 days for 6 months.
Standard of CareDrug
Also called Folic Acid, Proguanil, Penicillin V, Hydroxyurea
Folic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months
| Study group | Role | What they receive |
|---|---|---|
| Zinc Sulfate Tablet | Experimental | Zinc Sulfate Tablet 10 mg, 3 times a week plus Standard of Care for 6 months Receives: Dietary Supplement: Zinc Sulfate Tablets; Drug: Standard of Care |
| Control Arm | Placebo comparator | Standard of Care for 6 months Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of change in zinc levels from baseline at study conclusion.
Zinc Levels in Plasma
Measured: 6 months
Secondary outcomes (4)
Number of malaria episodes among recipients of zinc versus controls diagnosed by RDT or Microscopy.
Malaria Incidence
Measured: 6 months
Number of episodes of bacterial infections among recipients of zinc versus controls diagnosed by culture.
Bacterial Infection Incidence
Measured: 6 months
Incidence of malnutrition among recipients of zinc versus controls diagnosed based on anthropometric measurements.
Anthropometric Measurements i.e. Weight, Height and Mid Upper Arm Circumference
Measured: 6 months
Occurrences of Adverse Events (AEs) during the 6 month follow-up period among recipients of zinc versus controls.
Adverse Events including Serious Adverse Events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start20 May 2016
- Primary completion19 Jan 2017
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucas Otieno Tina, MD MSc
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Strathmore University
- Responsible party
- Sponsor-investigator, Lucas Otieno Tina, MD MSc, Kenya Medical Research Institute
- Investigators
- Lucas O Tina, MD MSc, Principal investigator, KEMRI/CREATES, Strathmore University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293641
- Sponsor's protocol ID
- KEMRI SSC 2925
- Status last verified
- Sep 2017
- First submitted
- 14 Apr 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya: a Pilot Study
- ClinicalTrials.gov ID
- NCT03293641
- Acronym / sponsor ID
- KEMRI SSC 2925
- Conditions
- Sickle Cell Disease, Zinc Deficiency, Infection
- Keywords
- Children, Sickle Cell Disease, Zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lucas Otieno Tina, MD MScUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Strathmore University
- Study start
- 20 May 2016 (actual)
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Zinc Sulfate Tablet | Experimental | Dietary Supplement: Zinc Sulfate Tablets, Drug: Standard of CareZinc Sulfate Tablet 10 mg, 3 times a week plus Standard of Care for 6 months |
| Control Arm | Placebo comparator | Drug: Standard of CareStandard of Care for 6 months |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Sulfate TabletsAlso: ZincosZinc Sulfate Tablets 3 times every 7 days for 6 months. | Dietary supplement | Zinc Sulfate Tablet |
| Standard of CareAlso: Folic Acid, Proguanil, Penicillin V, HydroxyureaFolic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months | Drug | Control Arm, Zinc Sulfate Tablet |
Primary outcome
Measurement of change in zinc levels from baseline at study conclusion.
Time frame: 6 months
Zinc Levels in Plasma
4 secondary outcomes
Number of malaria episodes among recipients of zinc versus controls diagnosed by RDT or Microscopy.
Time frame: 6 months
Number of episodes of bacterial infections among recipients of zinc versus controls diagnosed by culture.
Time frame: 6 months
Incidence of malnutrition among recipients of zinc versus controls diagnosed based on anthropometric measurements.
Time frame: 6 months
Occurrences of Adverse Events (AEs) during the 6 month follow-up period among recipients of zinc versus controls.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas O Tina, MD MSc principal investigator
KEMRI/CREATES, Strathmore University
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Sulfate Tablets in people with Sickle Cell Disease and Zinc Deficiency, run by Lucas Otieno Tina, MD MSc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of change in zinc levels from baseline at study conclusion. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.