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Completed

NCT Number: NCT03528434

Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

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).

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinja Reginal Referral Hospital

Jinja, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Zinc

Dietary Supplement

10mg dispersible zinc sulfate tablet

Placebo

Other

Dispersible tablet with inert ingredients, identical to zinc in appearance

Primary outcomes

  1. Incidence of infection

    Time frame: 12 months

    The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.

Secondary outcomes

  1. Incidence of all clinical infections

    Time frame: 12 months

    Incidence of all clinical infections

  2. Incidence of confirmed bacterial infections (by culture or PCR)

    Time frame: 12 months

    Incidence of confirmed bacterial infections (by culture or PCR)

  3. Incidence of vaso-occlusive crisis (VOC)

    Time frame: 12 months

    Incidence of vaso-occlusive crisis (VOC)

  4. Change in height-for-age z-score

    Time frame: Enrollment to 12 months

    Change in height-for-age z-score

  5. Incidence of zinc-related adverse events

    Time frame: 12 months

    Incidence of zinc-related adverse events

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Jinja Regional Referral Hospital
  • Makerere University
  • Université de Montréal

Registry information

Official study title

for Infection Prevention in Sickle Cell Anemia (ZIPS)

Acronym: ZIPS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 17, 2018
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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