Back to resultsOptimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
Primary Purpose
Anemia, Iron-deficiency, Iron Deficiency Anemia
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Ferrous Sulfate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Joint Clinical Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ferrous Sulfate
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
Hemoglobin
Measurement of hemoglobin
Anemia
Prevalence of anemia
Iron status
Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma
Secondary Outcome Measures
Sick Child Visits
Number of acute illnesses leading to visit to healthcare provider
Dietary iron absorption
Percentage of 57Fe from oral dose that is incorporated into hemoglobin
HIV virologic control
HIV viral load
HIV related immunosuppression
CD4 count
Full Information
NCT ID
NCT03596996
First Posted
June 5, 2018
Last Updated
August 19, 2020
Sponsor
University of Minnesota
Collaborators
Joint Clinical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT03596996
Brief Title
Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
Official Title
Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Joint Clinical Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-deficiency, Iron Deficiency Anemia, Hiv
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferrous Sulfate
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferrous Sulfate
Intervention Description
Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo with identical appearance comparison intervention arm
Primary Outcome Measure Information:
Title
Hemoglobin
Description
Measurement of hemoglobin
Time Frame
3 months
Title
Anemia
Description
Prevalence of anemia
Time Frame
3 months
Title
Iron status
Description
Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sick Child Visits
Description
Number of acute illnesses leading to visit to healthcare provider
Time Frame
3 months
Title
Dietary iron absorption
Description
Percentage of 57Fe from oral dose that is incorporated into hemoglobin
Time Frame
2 weeks
Title
HIV virologic control
Description
HIV viral load
Time Frame
3 month
Title
HIV related immunosuppression
Description
CD4 count
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Microbiome gut profile
Description
Ratio of Enterobacteriaceae to Lactobacillaceae and Bifidobacteriaceae
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Cusick, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint Clinical Research Centre
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
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