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Study protocol
Chandy C. John
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1634-1411
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Sickle cell anemia (SCA) is the most common inherited hemoglobinopathy worldwide. Infection is a major cause of illness and death in children with SCA, especially in sub Saharan Africa where an estimated 50-90% of affected children die before their fifth birthday. Interventions to reduce the incidence and severity of infections are needed urgently. A high proportion of adults and children with SCA are zinc-deficient, and zinc deficiency leads to impaired immunity and an increased risk of infection. Zinc supplementation has been shown to decrease the risk of infection in adolescents and adults, but there is no data on the effectiveness of zinc for prevention of infection in children <5 years of age with SCA.
Methods/Design
The study will be a randomized, placebo-controlled, double-blind clinical trial in which 250 Ugandan children 1.00-4.99 years of age with SCA will receive daily zinc supplementation (10 mg oral dispersible tablet) or identical placebo for 12 months.
Discussion
If this trial shows a reduction in severe or invasive infection incidence, it would be the basis for a multi-site, multi-country clinical trial to assess real-world safety and efficacy of zinc in African children with SCA. Since zinc is safe, inexpensive, and easy to administer, this trial has the potential to improve the health of hundreds of thousands of African children with SCA through reduction of infection-related morbidity and mortality.
Trial Registration
Clinicaltrials.gov identifier: NCT03528434. Registered on May 17, 2018 Protocol Version: 1.0. Date: Dec 11, 2017 Sponsor: Indiana University. Sponsor’s protocol identifier: 1712339562
Keywords
Sickle cell anemia, zinc, Uganda
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CURRENT STATUS: Published
View the published article at Trials.
Version 2
Posted 16 Jul, 2019
No community comments so far
Editorial decision: Accept
On 10 Jul, 2019
Editor assigned
On 09 Jul, 2019
Submission checks complete
On 08 Jul, 2019
No comments provided
Review #1 received
Received 01 Jul, 2019
Editorial decision: Minor revision
On 01 Jul, 2019
Reviewers invited
Invitations sent on 26 Apr, 2019
Reviewer #1 agreed
On 26 Apr, 2019
Editor assigned
On 17 Apr, 2019
Submission checks complete
On 20 Feb, 2019
First submitted
On 01 Feb, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Chandy C. John
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1634-1411
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 2
Posted 16 Jul, 2019
No community comments so far
Editorial decision: Accept
On 10 Jul, 2019
Editor assigned
On 09 Jul, 2019
Submission checks complete
On 08 Jul, 2019
No comments provided
Review #1 received
Received 01 Jul, 2019
Editorial decision: Minor revision
On 01 Jul, 2019
Reviewers invited
Invitations sent on 26 Apr, 2019
Reviewer #1 agreed
On 26 Apr, 2019
Editor assigned
On 17 Apr, 2019
Submission checks complete
On 20 Feb, 2019
First submitted
On 01 Feb, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background
Sickle cell anemia (SCA) is the most common inherited hemoglobinopathy worldwide. Infection is a major cause of illness and death in children with SCA, especially in sub Saharan Africa where an estimated 50-90% of affected children die before their fifth birthday. Interventions to reduce the incidence and severity of infections are needed urgently. A high proportion of adults and children with SCA are zinc-deficient, and zinc deficiency leads to impaired immunity and an increased risk of infection. Zinc supplementation has been shown to decrease the risk of infection in adolescents and adults, but there is no data on the effectiveness of zinc for prevention of infection in children <5 years of age with SCA.
Methods/Design
The study will be a randomized, placebo-controlled, double-blind clinical trial in which 250 Ugandan children 1.00-4.99 years of age with SCA will receive daily zinc supplementation (10 mg oral dispersible tablet) or identical placebo for 12 months.
Discussion
If this trial shows a reduction in severe or invasive infection incidence, it would be the basis for a multi-site, multi-country clinical trial to assess real-world safety and efficacy of zinc in African children with SCA. Since zinc is safe, inexpensive, and easy to administer, this trial has the potential to improve the health of hundreds of thousands of African children with SCA through reduction of infection-related morbidity and mortality.
Trial Registration
Clinicaltrials.gov identifier: NCT03528434. Registered on May 17, 2018 Protocol Version: 1.0. Date: Dec 11, 2017 Sponsor: Indiana University. Sponsor’s protocol identifier: 1712339562
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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