Using zinc to prevent infections in children with sickle cell anemia
Zinc for Infection Prevention in Sickle Cell Anemia-2
PHASE2; PHASE3 · Indiana University · NCT06561061
This study is testing if giving zinc to young children with sickle cell anemia can help prevent them from getting serious infections.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Months to 59 Months |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 1 site (Jinja) |
| Trial ID | NCT06561061 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blinded, placebo-controlled study aimed at evaluating the effectiveness of zinc in reducing the incidence of severe or invasive infections in Ugandan children aged 1 to 4 years with sickle cell anemia. Participants will receive either a daily oral dose of zinc (20 mg) or a placebo for a duration of six months. The primary outcome measure will be the incidence of infections from all causes during the study period. The trial is designed to provide insights into the potential role of zinc supplementation in improving health outcomes for these children.
Who should consider this trial
Good fit: Ideal candidates for this study are Ugandan children aged 1 to 4 years diagnosed with sickle cell anemia.
Not a fit: Patients with other chronic medical conditions or severe malnutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of infections in children with sickle cell anemia, improving their overall health and quality of life.
How similar studies have performed: Previous studies have shown promising results with zinc supplementation in reducing infection rates in various populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis) * Age range of 1.00-4.99 years, inclusive, at the time of enrollment * Weight at least 5.0 kg at the time of enrollment * Willingness to comply with all study-related treatments, evaluations, and follow-up * Children whose parents or guardians give full written informed consent Exclusion Criteria: * Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis) * Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age z-score \<-3, using WHO growth standards) * Absolute neutropenia (absolute neutrophil count \<500)
Where this trial is running
Jinja
- Jinja Hospital — Jinja, Uganda (RECRUITING)
Study contacts
- Principal investigator: Chandy C John, MD — Indiana University
- Study coordinator: Isaac Birungi
- Email: isaacbirun@gmail.com
- Phone: 0704236193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Disease, Zinc, All-cause infections