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

Study Overview
=================
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.

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

Conditions
-----------------
Anemia, Iron-deficiency, Iron Deficiency Anemia, Hiv

Intervention / Treatment
-----------------
* Dietary Supplement: Ferrous Sulfate
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferrous Sulfate<br>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<br>* Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo with identical appearance comparison intervention arm<br>|

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 |