NCT03596996

Brief Summary

Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation on iron status, gut microbiome profile, infectious disease frequency, and HIV disease severity in moderately anemic \[hemoglobin 9 - \<11 g/dL (6-59 mo); hemoglobin 9 - \< 11.5 g/dL (5 -12 years)\], HIV-infected Ugandan children between the ages of 6 mos and 12 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

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

Study Start

First participant enrolled

April 19, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

June 5, 2018

Last Update Submit

August 19, 2020

Conditions

AnemiaIron-deficiencyIron Deficiency AnemiaHiv

Outcome Measures

Primary Outcomes (3)

  • Hemoglobin

    Measurement of hemoglobin

    3 months

  • Anemia

    Prevalence of anemia

    3 months

  • Iron status

    Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma

    3 months

Secondary Outcomes (4)

  • Sick Child Visits

    3 months

  • Dietary iron absorption

    2 weeks

  • HIV virologic control

    3 month

  • HIV related immunosuppression

    3 months

Other Outcomes (1)

  • Microbiome gut profile

    3 months

Study Arms (2)

Ferrous Sulfate

EXPERIMENTAL

Children 6 to 23 months of age will receive a tablet that contains the equivalent of 12.5 mg of elemental iron. Children over 24 months will receive a tablet that contains the equivalent of 30 mg of elemental iron.

Dietary Supplement: Ferrous Sulfate

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Ferrous SulfateDIETARY_SUPPLEMENT

Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.

Ferrous Sulfate
PlaceboDIETARY_SUPPLEMENT

Placebo with identical appearance comparison intervention arm

Placebo

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Confirmed diagnosis of HIV (based JCRC clinic records);
  • On Highly Active Antiretroviral Treatment (HAART) for ≥ 6 months
  • Age 6 months - 12 years at the time of screening
  • Hemoglobin 9 - \<11 g/dL (6-59 mo); hemoglobin 9 - \< 11.5 g/dL (5 -12 years)by CBC at time of screening

You may not qualify if:

  • Acute illness or current opportunistic infection
  • Temperature \>= 38.0°C at the time of screening
  • Known sickle cell disease
  • Acute malnutrition (bilateral pitting edema or extreme wasting)
  • Any chronic illness requiring regular medical attention
  • Residence \> 50 km from JCRC hospital
  • Non-English or Luganda speaking
  • Currently taking iron supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Clinical Research Centre

Kampala, Uganda

Location

Related Publications (1)

  • Frosch AEP, Musiime V, Staley C, Conroy AL, Rutebarika D, Ategeka G, Cusick SE. Safety and efficacy of iron supplementation with 3 months of daily ferrous sulphate in children living with HIV and mild-to-moderate anaemia in Uganda: a double-blind, randomised, placebo-controlled trial. Lancet HIV. 2024 Nov;11(11):e727-e735. doi: 10.1016/S2352-3018(24)00238-8. Epub 2024 Oct 11.

    PMID: 39401504DERIVED

MeSH Terms

Conditions

AnemiaAnemia, Iron-DeficiencyAcquired Immunodeficiency Syndrome

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesAnemia, HypochromicIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sarah Cusick, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2018

First Posted

July 24, 2018

Study Start

April 19, 2018

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

August 21, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

IPD will be available on request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
IPD used for the current study are available after publication of primary findings on reasonable request. Requests may be subject to review by Joint Clinical Research Centre in Kampala, Uganda to determine if aims and analysis are consistent with participant consent.
Access Criteria
Joint Clinical Research Centre review to determine if aims and analysis on consistent with participant consent.

Locations

UG(1)