Daily Zinc Supplementation for Infection Prevention in Children With Sickle Cell Anemia: The ZIPS-2 Randomized Clinical Trial.
Daily zinc supplementation lowered infection rate in children with sickle cell anemia
Daily Zinc Supplementation for Infection Prevention in Children With Sickle Cell Anemia: The ZIPS-2 Randomized Clinical Trial.
IMPORTANCE: Despite existing prevention strategies, infections remain a major cause of morbidity and mortality in children in Africa with sickle cell anemia.
To determine the safety and effectiveness of daily zinc supplementation to prevent all-cause infection in children with sickle cell anemia in Uganda.
DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial of children aged 1.00 to 4.99 years with sickle cell anemia at Jinja Regional Referral Hospital in Jinja, Uganda, from February 10, 2025, to April 30, 2025, with 6 months of follow-up through November 7, 2025.
zinc cut infection rate by nearly 40% versus placebo
Among 118 children screened for eligibility, 100 were randomly assigned to receive zinc supplementation (n = 50) or placebo (n = 50) (mean [SD] age, 36.0 [13.2] months; 45 female [45%]).
At enrollment, 45 participants (45%) were receiving hydroxyurea therapy.
All participants initiated or continued receiving hydroxyurea after enrollment.
During the 6-month follow-up, there was complete ascertainment for all participants and no loss to follow-up.
Zinc supplementation at 20 mg per day reduced all-cause infection in children with sickle cell anemia younger than 5 years in Uganda.
Multisite clinical trials are needed to validate these findings and to assess effectiveness in older children.