Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Iron status
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Intervention: Placebo (Dietary Supplement)
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.
Intervention: Ferrous Sulfate (Dietary Supplement)
Outcomes
Primary Outcomes
Iron status
Time Frame: 3 months
Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma
Hemoglobin
Time Frame: 3 months
Measurement of hemoglobin
Anemia
Time Frame: 3 months
Prevalence of anemia
Secondary Outcomes
- Dietary iron absorption(2 weeks)
- Sick Child Visits(3 months)
- HIV virologic control(3 month)
- HIV related immunosuppression(3 months)