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

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Zinc
Placebo
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sickle Cell Disease focused on measuring Zinc

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Jinja Reginal Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zinc

Placebo

Arm Description

Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet

Dispersible tablet with inert ingredients, identical to zinc in appearance

Outcomes

Primary Outcome Measures

Incidence of infection
The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.

Secondary Outcome Measures

Incidence of all clinical infections
Incidence of all clinical infections
Incidence of confirmed bacterial infections (by culture or PCR)
Incidence of confirmed bacterial infections (by culture or PCR)
Incidence of vaso-occlusive crisis (VOC)
Incidence of vaso-occlusive crisis (VOC)
Change in height-for-age z-score
Change in height-for-age z-score
Incidence of zinc-related adverse events
Incidence of zinc-related adverse events

Full Information

First Posted
May 7, 2018
Last Updated
February 8, 2021
Sponsor
Indiana University
Collaborators
Children's Hospital Medical Center, Cincinnati, Makerere University, Jinja Regional Referral Hospital, Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT03528434
Brief Title
Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)
Acronym
ZIPS
Official Title
for Infection Prevention in Sickle Cell Anemia (ZIPS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
November 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Children's Hospital Medical Center, Cincinnati, Makerere University, Jinja Regional Referral Hospital, Université de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Zinc

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, placebo-controlled, double blind clinical trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc
Arm Type
Experimental
Arm Description
Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dispersible tablet with inert ingredients, identical to zinc in appearance
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Description
10mg dispersible zinc sulfate tablet
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Dispersible tablet with inert ingredients, identical to zinc in appearance
Primary Outcome Measure Information:
Title
Incidence of infection
Description
The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of all clinical infections
Description
Incidence of all clinical infections
Time Frame
12 months
Title
Incidence of confirmed bacterial infections (by culture or PCR)
Description
Incidence of confirmed bacterial infections (by culture or PCR)
Time Frame
12 months
Title
Incidence of vaso-occlusive crisis (VOC)
Description
Incidence of vaso-occlusive crisis (VOC)
Time Frame
12 months
Title
Change in height-for-age z-score
Description
Change in height-for-age z-score
Time Frame
Enrollment to 12 months
Title
Incidence of zinc-related adverse events
Description
Incidence of zinc-related adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis) Age range of 1.00-4.99 years, inclusive, at the time of enrollment Weight at least 5.0 kg at the time of enrollment Willingness to comply with all study-related treatments, evaluations, and follow-up Exclusion Criteria: Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis) 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandy C. John, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinja Reginal Referral Hospital
City
Jinja
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31349866
Citation
Datta D, Namazzi R, Conroy AL, Cusick SE, Hume HA, Tagoola A, Ware RE, Opoka RO, John CC. Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia. Trials. 2019 Jul 26;20(1):460. doi: 10.1186/s13063-019-3569-z.
Results Reference
derived

Learn more about this trial

Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

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