Trial | NCT03528434  Report issue

Title

Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)
for Infection Prevention in Sickle Cell Anemia (ZIPS)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Zinc ...

  • Study Participants

    250
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).
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 Started
Mar 14
2019
Primary Completion
Nov 23
2020
Study Completion
Nov 23
2020
Last Update
Feb 09
2021

Dietary Supplement Zinc

10mg dispersible zinc sulfate tablet

Other Placebo

Dispersible tablet with inert ingredients, identical to zinc in appearance

Zinc Experimental

Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet

  • Dietary Supplement Zinc

Placebo Placebo Comparator

Dispersible tablet with inert ingredients, identical to zinc in appearance

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

Exclusion Criteria:

Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
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)
No Results Posted