NCT03528434

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

March 14, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

May 7, 2018

Last Update Submit

February 8, 2021

Conditions

Sickle Cell Disease

Keywords

Zinc

Outcome Measures

Primary Outcomes (1)

  • Incidence of infection

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

    12 months

Secondary Outcomes (5)

  • Incidence of all clinical infections

    12 months

  • Incidence of confirmed bacterial infections (by culture or PCR)

    12 months

  • Incidence of vaso-occlusive crisis (VOC)

    12 months

  • Change in height-for-age z-score

    Enrollment to 12 months

  • Incidence of zinc-related adverse events

    12 months

Study Arms (2)

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

Other: Placebo

Interventions

ZincDIETARY_SUPPLEMENT

10mg dispersible zinc sulfate tablet

Zinc
PlaceboOTHER

Dispersible tablet with inert ingredients, identical to zinc in appearance

Placebo

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinja Reginal Referral Hospital

Jinja, Uganda

Location

Related Publications (3)

  • Bolarinwa AB, Oduwole O, Okebe J, Ogbenna AA, Otokiti OE, Olatinwo AT. Antioxidant supplementation for sickle cell disease. Cochrane Database Syst Rev. 2024 May 22;5(5):CD013590. doi: 10.1002/14651858.CD013590.pub2.

    PMID: 38775255DERIVED

  • Namazzi R, Opoka R, Conroy AL, Datta D, Tagoola A, Bond C, Goings MJ, Ryu MS, Cusick SE, Krebs NF, Jang JH, Tu W, Ware RE, John CC. Zinc for infection prevention in children with sickle cell anemia: a randomized double-blind placebo-controlled trial. Blood Adv. 2023 Jul 11;7(13):3023-3031. doi: 10.1182/bloodadvances.2022008539.

    PMID: 36735400DERIVED

  • 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.

    PMID: 31349866DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Zinc

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Chandy C. John, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized, placebo-controlled, double blind clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 17, 2018

Study Start

March 14, 2019

Primary Completion

November 23, 2020

Study Completion

November 23, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)