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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
NCT03528434 |
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Date of registration:
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07/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)
ZIPS |
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Scientific title:
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for Infection Prevention in Sickle Cell Anemia (ZIPS) |
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Date of first enrolment:
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March 14, 2019 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03528434 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Chandy C. John, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indiana University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)
2. Age range of 1.00-4.99 years, inclusive, at the time of enrollment
3. Weight at least 5.0 kg at the time of enrollment
4. Willingness to comply with all study-related treatments, evaluations, and follow-up
Exclusion Criteria:
1. Known other chronic medical condition (e.g., HIV, malignancy, active clinical
tuberculosis)
2. Severe malnutrition determined by impaired growth parameters as defined by the World
Health Organization (WHO) (weight for length/height or height for age z-score <-3,
using WHO growth standards)
Age minimum:
1 Year
Age maximum:
5 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sickle Cell Disease
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Intervention(s)
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Dietary Supplement: Zinc
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Other: Placebo
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Primary Outcome(s)
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Incidence of infection
[Time Frame: 12 months]
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Secondary Outcome(s)
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Incidence of zinc-related adverse events
[Time Frame: 12 months]
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Incidence of vaso-occlusive crisis (VOC)
[Time Frame: 12 months]
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Change in height-for-age z-score
[Time Frame: Enrollment to 12 months]
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Incidence of all clinical infections
[Time Frame: 12 months]
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Incidence of confirmed bacterial infections (by culture or PCR)
[Time Frame: 12 months]
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Secondary ID(s)
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1712339562
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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