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

• ClinicalTrials.gov Identifier: NCT03528434
• Recruitment Status: Completed
• First Posted: May 17, 2018
• Last Update Posted: February 9, 2021
• Sponsor: Indiana University
• 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

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).

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: November 23, 2020
• Actual Study Completion Date: November 23, 2020

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

Uganda

Jinja Reginal Referral Hospital

Jinja, Uganda

Sponsors and Collaborators

Indiana University

Children's Hospital Medical Center, Cincinnati

Makerere University

Jinja Regional Referral Hospital

Université de Montréal

Investigators

• Principal Investigator: Chandy C. John, MD; Indiana University

  Study Documents (Full-Text)

Documents provided by Chandy John, Indiana University:

Study Protocol and Statistical Analysis Plan  [PDF] December 11, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Chandy John, Professor of Pediatrics, Indiana University
• ClinicalTrials.gov Identifier: NCT03528434
• Other Study ID Numbers: 1712339562
• First Posted: May 17, 2018
• Last Update Posted: February 9, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Anemia, Sickle Cell; Anemia; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Genetic Diseases, Inborn