Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

Sickle Cell Disease Clinical Trial

— ZIPS  

Official title:

for Infection Prevention in Sickle Cell Anemia (ZIPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528434
• Other study ID #: 1712339562
• Status: Completed
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: November 23, 2020

Study information

• Verified date: February 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Dietary Supplement:
• Zinc
10mg dispersible zinc sulfate tablet

Other:
• Placebo
Dispersible tablet with inert ingredients, identical to zinc in appearance

Locations

Country	Name	City	State
Uganda	Jinja Reginal Referral Hospital	Jinja

Sponsors (5)

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

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of infection	The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.	12 months
Secondary	Incidence of all clinical infections	Incidence of all clinical infections	12 months
Secondary	Incidence of confirmed bacterial infections (by culture or PCR)	Incidence of confirmed bacterial infections (by culture or PCR)	12 months
Secondary	Incidence of vaso-occlusive crisis (VOC)	Incidence of vaso-occlusive crisis (VOC)	12 months
Secondary	Change in height-for-age z-score	Change in height-for-age z-score	Enrollment to 12 months
Secondary	Incidence of zinc-related adverse events	Incidence of zinc-related adverse events	12 months