Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Anemia; Hiv; Iron Deficiency Anemia
• Intervention / Treatment: Dietary supplement: Ferrous Sulfate; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Joint Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo with identical appearance comparison intervention arm
Experimental: Ferrous Sulfate; 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; Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sick Child Visits	Number of acute illnesses leading to visit to healthcare provider	3 months
Dietary iron absorption	Percentage of 57Fe from oral dose that is incorporated into hemoglobin	2 weeks
HIV virologic control	HIV viral load	3 month
HIV related immunosuppression	CD4 count	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome gut profile	Ratio of Enterobacteriaceae to Lactobacillaceae and Bifidobacteriaceae	3 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Joint Clinical Research Center
• Investigators: Principal Investigator: Sarah Cusick, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia
• Other Study ID Numbers: 1608M92324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be available on request.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Joint Clinical Research Centre review to determine if aims and analysis on consistent with participant consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No