Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

for Infection Prevention in Sickle Cell Anemia (ZIPS)

Sponsors

Lead Sponsor: Indiana University

Collaborator: Children's Hospital Medical Center, Cincinnati
Makerere University
Jinja Regional Referral Hospital
Université de Montréal

Source Indiana University
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 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.

Overall Status Recruiting
Start Date March 14, 2019
Completion Date January 1, 2021
Primary Completion Date January 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of infection 12 months
Secondary Outcome
Measure Time Frame
Incidence of all clinical infections 12 months
Incidence of confirmed bacterial infections (by culture or PCR) 12 months
Incidence of vaso-occlusive crisis (VOC) 12 months
Change in height-for-age z-score Enrollment to 12 months
Incidence of zinc-related adverse events 12 months
Enrollment 250
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Zinc

Description: 10mg dispersible zinc sulfate tablet

Arm Group Label: Zinc

Intervention Type: Other

Intervention Name: Placebo

Description: Dispersible tablet with inert ingredients, identical to zinc in appearance

Arm Group Label: Placebo

Eligibility

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)

Gender: All

Minimum Age: 1 Year

Maximum Age: 5 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Chandy C. John, MD Principal Investigator Indiana University
Overall Contact

Last Name: Carrie Nijak, RN

Phone: +1 317 274 8804

Email: [email protected]

Location
Facility: Status: Contact: Jinja Reginal Referral Hospital Robert Opoka, MD +256 772996164 [email protected]
Location Countries

Uganda

Verification Date

December 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Indiana University

Investigator Full Name: Chandy John

Investigator Title: Professor of Pediatrics

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Zinc

Type: Experimental

Description: Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet

Label: Placebo

Type: Placebo Comparator

Description: Dispersible tablet with inert ingredients, identical to zinc in appearance

Acronym ZIPS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: A randomized, placebo-controlled, double blind clinical trial

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov