Sickle Cell DiseasePhase 2/3ZIPS-2NCT06561061
Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)
A Phase 2/3 study testing zinc sulfate in people with Sickle Cell Disease, run by Indiana University at 1 site in Uganda.
Trial 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) Read more about this study
- Who is it for?
- Ages 12 to 59 months
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- zinc sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUganda
- Study dates
- 10 Feb 2025to 7 Nov 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zinc for Infection Prevention in Sickle Cell Anemia-2
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)
Read the 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).
- Conditions
- Sickle Cell Disease
- Being tested
- zinc sulfate, Placebo
- Keywords
- Zinc, All-cause infections
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc sulfateDrug
Dispersible (20 mg) tablet
PlaceboDrug
Dispersible tablet
| Study group | Role | What they receive |
|---|---|---|
| Zinc | Experimental | Dispersible zinc sulfate tablet (20 mg) Receives: Drug: zinc sulfate |
| Placebo | Placebo comparator | Dispersible identical placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Incidence of infections requiring hospitalization
Incidence of Advance events greater or equal to grade 3
Measured: 6 months
Incidence of adverse events requiring discontinuation of study drug
Incidence of Zinc related Advance events
Measured: 6 months
Incidence of stroke or death
Incidence of death and stroke
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start10 Feb 2025
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized double-blinded placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Global Health Uganda LTD, Makerere University
- Responsible party
- Principal investigator, Chandy John, Indiana University
- Investigators
- Chandy C John, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561061
- Sponsor's protocol ID
- 2023-841
- Acronym
- ZIPS-2
- Status last verified
- Feb 2025
- First submitted
- 16 Aug 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Namazzi R, Mellencamp KA, Bagala I, Conroy AL, Kato C, Birungi I, Kasembo P, Kyarisiima G, Tenywa E, Ren J, Goings MJ, Cusick SE, John CC. Daily Zinc Supplementation for Infection Prevention in Children With Sickle Cell Anemia: The ZIPS-2 Randomized Clinical Trial. JAMA. 2026 Aug 19:e2614190. doi: 10.1001/jama.2026.14190. Online ahead of print.
PubMed 42616536
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc for Infection Prevention in Sickle Cell Anemia-2
- ClinicalTrials.gov ID
- NCT06561061
- Acronym / sponsor ID
- ZIPS-2 / 2023-841
- Conditions
- Sickle Cell Disease
- Keywords
- Zinc, All-cause infections
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Global Health Uganda LTD, Makerere University
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomized double-blinded placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Zinc | Experimental | Drug: zinc sulfateDispersible zinc sulfate tablet (20 mg) |
| Placebo | Placebo comparator | Drug: PlaceboDispersible identical placebo tablet |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc sulfateDispersible (20 mg) tablet | Drug | Zinc |
| PlaceboDispersible tablet | Drug | Placebo |
Primary outcome
Incidence of all-cause infections in the zinc vs. placebo groups
Time frame: 6 months
Will assess the difference in the incidence of all cause infection between the Placebo arm and the experimental arm
3 secondary outcomes
Incidence of infections requiring hospitalization
Time frame: 6 months
Incidence of adverse events requiring discontinuation of study drug
Time frame: 6 months
Incidence of stroke or death
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 42616536Namazzi R, Mellencamp KA, Bagala I, Conroy AL, Kato C, Birungi I, Kasembo P, Kyarisiima G, Tenywa E, Ren J, Goings MJ, Cusick SE, John CC. Daily Zinc Supplementation for Infection Prevention in Children With Sickle Cell Anemia: The ZIPS-2 Randomized Clinical Trial. JAMA. 2026 Aug 19:e2614190. doi: 10.1001/jama.2026.14190. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandy C John, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing zinc sulfate in people with Sickle Cell Disease, run by Indiana University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all-cause infections in the zinc vs. placebo groups (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.