Clinical trial NCT03528434: Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)
Official title: for Infection Prevention in Sickle Cell Anemia (ZIPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Zinc
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: Makerere University
name: Jinja Regional Referral Hospital
name: Université de Montréal
First posted: 2018-05-17
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, placebo-controlled, double blind clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of infection
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of all clinical infections
timeFrame: 12 months
measure: Incidence of confirmed bacterial infections (by culture or PCR)
timeFrame: 12 months
measure: Incidence of vaso-occlusive crisis (VOC)
timeFrame: 12 months
measure: Change in height-for-age z-score
timeFrame: Enrollment to 12 months
measure: Incidence of zinc-related adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Jinja
country: Uganda
facility: Jinja Reginal Referral Hospital
Study officials:
affiliation: Indiana University
name: Chandy C. John, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Datta D, Namazzi R, Conroy AL, Cusick SE, Hume HA, Tagoola A, Ware RE, Opoka RO, John CC. Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia. Trials. 2019 Jul 26;20(1):460. doi: 10.1186/s13063-019-3569-z.