Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-20 @ 12:47 PM
Study NCT ID:
NCT03528434
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2018-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
for Infection Prevention in Sickle Cell Anemia (ZIPS)
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZIPS
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: