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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596996
• Other study ID #: 1608M92324
• Status: Completed
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: February 10, 2020

Study information

• Verified date: August 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Hiv
• Iron Deficiency Anemia
• Iron-deficiency

Intervention

Dietary Supplement:
• Ferrous Sulfate
Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.
• Placebo
Placebo with identical appearance comparison intervention arm

Locations

Country	Name	City	State
Uganda	Joint Clinical Research Centre	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Joint Clinical Research Center

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiome gut profile	Ratio of Enterobacteriaceae to Lactobacillaceae and Bifidobacteriaceae	3 months
Primary	Hemoglobin	Measurement of hemoglobin	3 months
Primary	Anemia	Prevalence of anemia	3 months
Primary	Iron status	Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma	3 months
Secondary	Sick Child Visits	Number of acute illnesses leading to visit to healthcare provider	3 months
Secondary	Dietary iron absorption	Percentage of 57Fe from oral dose that is incorporated into hemoglobin	2 weeks
Secondary	HIV virologic control	HIV viral load	3 month
Secondary	HIV related immunosuppression	CD4 count	3 months