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Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS) (ZIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528434
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : December 6, 2019
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Makerere University
Jinja Regional Referral Hospital
Université de Montréal
Information provided by (Responsible Party):
Chandy John, Indiana University

Brief Summary:
A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA).

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Dietary Supplement: Zinc Other: Placebo Not Applicable

Detailed Description:
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 zinc (10 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 12 months. The primary study outcome will be incidence of severe or invasive infections. Secondary outcomes will include incidence of all clinical infections, confirmed bacterial infections (by culture or PCR), incidence of vaso-occlusive crisis (VOC), change in height-for-age z-score, and incidence of zinc-related adverse events.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, placebo-controlled, double blind clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: for Infection Prevention in Sickle Cell Anemia (ZIPS)
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: Zinc
Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet
Dietary Supplement: Zinc
10mg dispersible zinc sulfate tablet

Placebo Comparator: Placebo
Dispersible tablet with inert ingredients, identical to zinc in appearance
Other: Placebo
Dispersible tablet with inert ingredients, identical to zinc in appearance




Primary Outcome Measures :
  1. Incidence of infection [ Time Frame: 12 months ]
    The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.


Secondary Outcome Measures :
  1. Incidence of all clinical infections [ Time Frame: 12 months ]
    Incidence of all clinical infections

  2. Incidence of confirmed bacterial infections (by culture or PCR) [ Time Frame: 12 months ]
    Incidence of confirmed bacterial infections (by culture or PCR)

  3. Incidence of vaso-occlusive crisis (VOC) [ Time Frame: 12 months ]
    Incidence of vaso-occlusive crisis (VOC)

  4. Change in height-for-age z-score [ Time Frame: Enrollment to 12 months ]
    Change in height-for-age z-score

  5. Incidence of zinc-related adverse events [ Time Frame: 12 months ]
    Incidence of zinc-related adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528434


Contacts
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Contact: Carrie Nijak, RN +1 317 274 8804 cnijak@yahoo.com
Contact: Ruth Namazzi, MBChB +256 772 356 331 namazzi101@gmail.com

Locations
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Uganda
Jinja Reginal Referral Hospital Recruiting
Jinja, Uganda
Contact: Robert Opoka, MD    +256 772996164    opokabob@yahoo.com   
Sponsors and Collaborators
Indiana University
Children's Hospital Medical Center, Cincinnati
Makerere University
Jinja Regional Referral Hospital
Université de Montréal
Investigators
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Principal Investigator: Chandy C. John, MD Indiana University
  Study Documents (Full-Text)

Documents provided by Chandy John, Indiana University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chandy John, Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT03528434    
Other Study ID Numbers: 1712339562
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chandy John, Indiana University:
Zinc
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn