Sickle Cell DiseaseZIPSNCT03528434
Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)
A study testing Zinc 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 1 year to 5 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUganda
- Study dates
- 14 Mar 2019to 23 Nov 2020
- Phase
- Interventional
- 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 1 year to 5 years
- 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
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 the World Health Organization (WHO) (weight for length/height or height for age z-score <-3, using WHO growth standards)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: for Infection Prevention in Sickle Cell Anemia (ZIPS)
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 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Zinc, Placebo
- Keywords
- Zinc
- 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.
ZincDietary supplement
10mg dispersible zinc sulfate tablet
PlaceboOther
Dispersible tablet with inert ingredients, identical to zinc in appearance
| Study group | Role | What they receive |
|---|---|---|
| Zinc | Experimental | Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet Receives: Dietary Supplement: Zinc |
| Placebo | Placebo comparator | Dispersible tablet with inert ingredients, identical to zinc in appearance Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infection
The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.
Measured: 12 months
Secondary outcomes (5)
Incidence of all clinical infections
Incidence of all clinical infections
Measured: 12 months
Incidence of confirmed bacterial infections (by culture or PCR)
Incidence of confirmed bacterial infections (by culture or PCR)
Measured: 12 months
Incidence of vaso-occlusive crisis (VOC)
Incidence of vaso-occlusive crisis (VOC)
Measured: 12 months
Change in height-for-age z-score
Change in height-for-age z-score
Measured: Enrollment to 12 months
Incidence of zinc-related adverse events
Incidence of zinc-related adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start14 Mar 2019
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo-controlled, double blind clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Makerere University, Jinja Regional Referral Hospital, Université de Montréal
- Responsible party
- Principal investigator, Chandy John, Indiana University
- Investigators
- Chandy C. John, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528434
- Sponsor's protocol ID
- 1712339562
- Acronym
- ZIPS
- Status last verified
- Feb 2021
- First submitted
- 7 May 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Namazzi R, Opoka RO, Ssuuna C, Goings MJ, McElhinney K, Datta D, Ware RE, John CC, Conroy AL. Hydroxyurea interferes with point-of-care creatinine testing in children with sickle cell anemia. BMC Res Notes. 2026 Jun 19. doi: 10.1186/s13104-026-07916-1. Online ahead of print.
PubMed 42321870Bolarinwa AB, Oduwole O, Okebe J, Ogbenna AA, Otokiti OE, Olatinwo AT. Antioxidant supplementation for sickle cell disease. Cochrane Database Syst Rev. 2024 May 22;5(5):CD013590. doi: 10.1002/14651858.CD013590.pub2.
PubMed 38775255Namazzi R, Opoka R, Conroy AL, Datta D, Tagoola A, Bond C, Goings MJ, Ryu MS, Cusick SE, Krebs NF, Jang JH, Tu W, Ware RE, John CC. Zinc for infection prevention in children with sickle cell anemia: a randomized double-blind placebo-controlled trial. Blood Adv. 2023 Jul 11;7(13):3023-3031. doi: 10.1182/bloodadvances.2022008539.
PubMed 36735400Datta 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.
PubMed 31349866
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- for Infection Prevention in Sickle Cell Anemia (ZIPS)
- ClinicalTrials.gov ID
- NCT03528434
- Acronym / sponsor ID
- ZIPS / 1712339562
- Conditions
- Sickle Cell Disease
- Keywords
- Zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Makerere University, Jinja Regional Referral Hospital, Université de Montréal
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 17 May 2018 (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 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.
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, placebo-controlled, double blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Zinc | Experimental | Dietary Supplement: ZincDietary Supplement: Zinc 10mg dispersible zinc sulfate tablet |
| Placebo | Placebo comparator | Other: PlaceboDispersible tablet with inert ingredients, identical to zinc in appearance |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 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
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Zinc10mg dispersible zinc sulfate tablet | Dietary supplement | Zinc |
| PlaceboDispersible tablet with inert ingredients, identical to zinc in appearance | Other | Placebo |
Primary outcome
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.
5 secondary outcomes
Incidence of all clinical infections
Time frame: 12 months
Incidence of confirmed bacterial infections (by culture or PCR)
Time frame: 12 months
Incidence of vaso-occlusive crisis (VOC)
Time frame: 12 months
Change in height-for-age z-score
Time frame: Enrollment to 12 months
Incidence of zinc-related adverse events
Time frame: 12 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 9 Feb 2021.
- Derived from this study: PubMed 42321870Namazzi R, Opoka RO, Ssuuna C, Goings MJ, McElhinney K, Datta D, Ware RE, John CC, Conroy AL. Hydroxyurea interferes with point-of-care creatinine testing in children with sickle cell anemia. BMC Res Notes. 2026 Jun 19. doi: 10.1186/s13104-026-07916-1. Online ahead of print.
- Derived from this study: PubMed 38775255Bolarinwa AB, Oduwole O, Okebe J, Ogbenna AA, Otokiti OE, Olatinwo AT. Antioxidant supplementation for sickle cell disease. Cochrane Database Syst Rev. 2024 May 22;5(5):CD013590. doi: 10.1002/14651858.CD013590.pub2.
- Derived from this study: PubMed 36735400Namazzi R, Opoka R, Conroy AL, Datta D, Tagoola A, Bond C, Goings MJ, Ryu MS, Cusick SE, Krebs NF, Jang JH, Tu W, Ware RE, John CC. Zinc for infection prevention in children with sickle cell anemia: a randomized double-blind placebo-controlled trial. Blood Adv. 2023 Jul 11;7(13):3023-3031. doi: 10.1182/bloodadvances.2022008539.
- Derived from this study: PubMed 31349866Datta 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.
- 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 study testing Zinc 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 4 inclusion and 2 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 9 Feb 2021. 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.
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 infection (time frame: 12 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 NCT03528434, which also lists 4 linked publications.
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 9 Feb 2021.