NCT03528434

Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

for Infection Prevention in Sickle Cell Anemia (ZIPS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Zinc	10mg dispersible zinc sulfate tablet
OTHER	Placebo	Dispersible tablet with inert ingredients, identical to zinc in appearance

Timeline

• Start date: 2019-03-14
• Primary completion: 2020-11-23
• Completion: 2020-11-23
• First posted: 2018-05-17
• Last updated: 2021-02-09

Locations

1 site across 1 country: Uganda