Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03528434
• Collaborator: Children's Hospital Medical Center, Cincinnati (Other), Makerere University (Other), Jinja Regional Referral Hospital (Other), Université de Montréal (Other)
• Enrollment: 250
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.4
• Patients Per Site Per Month: 12.3

Study Details

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	N/A

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
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized, placebo-controlled, double blind clinical trialA 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: Mar 14, 2019
• Actual Primary Completion Date: Nov 23, 2020
• Actual Study Completion Date: Nov 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 [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 [12 months]

   Incidence of all clinical infections

2. Incidence of confirmed bacterial infections (by culture or PCR) [12 months]

   Incidence of confirmed bacterial infections (by culture or PCR)

3. Incidence of vaso-occlusive crisis (VOC) [12 months]

   Incidence of vaso-occlusive crisis (VOC)

4. Change in height-for-age z-score [Enrollment to 12 months]

   Change in height-for-age z-score

5. Incidence of zinc-related adverse events [12 months]

   Incidence of zinc-related adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol and Statistical Analysis Plan - Dec 11, 2017

More Information

Publications

None provided.

• 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: Feb 9, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Professor of Pediatrics, Indiana University: Zinc
• Additional relevant MeSH terms: Anemia, Sickle Cell

Study Results

No Results Posted as of Feb 9, 2021