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

University of Minnesota (UMN)

Status: Completed

Conditions: Iron Deficiency Anemia; Anemia; Iron-deficiency; Hiv

Treatments: Dietary Supplement: Ferrous Sulfate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03596996

1608M92324

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Ferrous Sulfate

Experimental group

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.

Treatment:

Dietary Supplement: Ferrous Sulfate

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo