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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.
Placebo with identical appearance comparison intervention arm
Joint Clinical Research Centre
Kampala, Uganda
Hemoglobin
Measurement of hemoglobin
Time frame: 3 months
Anemia
Prevalence of anemia
Time frame: 3 months
Iron status
Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma
Time frame: 3 months
Sick Child Visits
Number of acute illnesses leading to visit to healthcare provider
Time frame: 3 months
Dietary iron absorption
Percentage of 57Fe from oral dose that is incorporated into hemoglobin
Time frame: 2 weeks
HIV virologic control
HIV viral load
Time frame: 3 month
HIV related immunosuppression
CD4 count
Time frame: 3 months
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