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| Name | Class |
|---|---|
| Joint Clinical Research Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous Sulfate | Experimental | 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 Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Sulfate | Dietary Supplement | Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome gut profile | Ratio of Enterobacteriaceae to Lactobacillaceae and Bifidobacteriaceae | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Cusick, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Clinical Research Centre | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39401504 | Derived | Frosch AEP, Musiime V, Staley C, Conroy AL, Rutebarika D, Ategeka G, Cusick SE. Safety and efficacy of iron supplementation with 3 months of daily ferrous sulphate in children living with HIV and mild-to-moderate anaemia in Uganda: a double-blind, randomised, placebo-controlled trial. Lancet HIV. 2024 Nov;11(11):e727-e735. doi: 10.1016/S2352-3018(24)00238-8. Epub 2024 Oct 11. |
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IPD will be available on request.
IPD used for the current study are available after publication of primary findings on reasonable request. Requests may be subject to review by Joint Clinical Research Centre in Kampala, Uganda to determine if aims and analysis are consistent with participant consent.
Joint Clinical Research Centre review to determine if aims and analysis on consistent with participant consent.
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D000090463 | Iron Deficiencies |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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| Placebo | Dietary Supplement | Placebo with identical appearance comparison intervention arm |
|
| 2 weeks |
| HIV virologic control | HIV viral load | 3 month |
| HIV related immunosuppression | CD4 count | 3 months |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |