Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZI... | NCT06561061

Studies
Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)

NCT06561061

Sponsor

Indiana University

Status

Completed

Last Update Posted

Jan 30, 2026Actual

Enrollment

100Actual

Phase

Phase 2Phase 3

Conditions

Sickle Cell Disease

Interventions

zinc sulfate
Placebo

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2025Actual

Primary Completion Date

Nov 7, 2025Actual

Completion Date

Nov 7, 2025Actual

First Submitted Date

Aug 16, 2024

First Submission Date that Met QC Criteria

Aug 16, 2024

First Posted Date

Aug 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2026

Last Update Posted Date

Jan 30, 2026Actual

Name	Class
Global Health Uganda LTD	OTHER
Makerere University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 100 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (20 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 6 months. The primary study outcome will be incidence of infection (all causes).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Zinc	Experimental	Dispersible zinc sulfate tablet (20 mg)	Drug: zinc sulfate
Placebo	Placebo Comparator	Dispersible identical placebo tablet	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
zinc sulfate	Drug	Dispersible (20 mg) tablet	Zinc
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of all-cause infections in the zinc vs. placebo groups	Will assess the difference in the incidence of all cause infection between the Placebo arm and the experimental arm	6 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of infections requiring hospitalization	Incidence of Advance events greater or equal to grade 3	6 months
Incidence of adverse events requiring discontinuation of study drug	Incidence of Zinc related Advance events

Other Outcomes

Measure	Description	Time Frame
Change in Transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint	Change in TCD Velocity	6 months

Eligibility Module

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
Children whose parents or guardians give full written informed consent

Exclusion Criteria:

Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age z-score <-3, using WHO growth standards)
Absolute neutropenia (absolute neutrophil count <500)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

59 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chandy C John, MD	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinja Hospital		Jinja			Uganda

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019287	Zinc Sulfate

Ancestor Terms

ID	Term
D013431	Sulfates
D013464	Sulfuric Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided