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

Not Applicable

Completed

• Conditions: Iron-deficiency; Anemia; Hiv; Iron Deficiency Anemia
• Interventions: Dietary Supplement: Ferrous Sulfate; Dietary Supplement: Placebo

• Registration Number: NCT03596996
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-19
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-24
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferrous Sulfate	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.
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Anemia	3 months	Prevalence of anemia
Iron status	3 months	Iron status measured using ferritin, sTfR, CRP and hepcidin concentration in plasma
Hemoglobin	3 months	Measurement of hemoglobin

Secondary Outcome Measures

Name	Time	Method
Dietary iron absorption	2 weeks	Percentage of 57Fe from oral dose that is incorporated into hemoglobin
Sick Child Visits	3 months	Number of acute illnesses leading to visit to healthcare provider
HIV virologic control	3 month	HIV viral load
HIV related immunosuppression	3 months	CD4 count

Trial Locations

Locations (1)

Joint Clinical Research Centre; 🇺🇬 Kampala, Uganda