Anemia, Hiv, Iron-deficiency, Iron Deficiency Anemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFerrous Sulfate
Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.
DIETARY_SUPPLEMENTPlacebo
Placebo with identical appearance comparison intervention arm
Sponsors
Joint Clinical Research Center
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Iron status | 3 months | Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma |
| Hemoglobin | 3 months | Measurement of hemoglobin |
| Anemia | 3 months | Prevalence of anemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV virologic control | 3 month | HIV viral load |
| HIV related immunosuppression | 3 months | CD4 count |
| Sick Child Visits | 3 months | Number of acute illnesses leading to visit to healthcare provider |
| Dietary iron absorption | 2 weeks | Percentage of 57Fe from oral dose that is incorporated into hemoglobin |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbiome gut profile | 3 months | Ratio of Enterobacteriaceae to Lactobacillaceae and Bifidobacteriaceae |
Countries
Uganda
Outcome results
None listed