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Reports from the Kenya Red Cross Society (KRCS) in Kwale County, southern Kenya, indicate a limited impact of Ready-to-Use Therapeutic Foods (RUTFs) on malnutrition or anemia. The current RUTF formulation may have an excessively high iron content. In severely acutely malnourished (SAM) children, iron cannot be properly absorbed, leading to life-threatening diarrhea. The overall aim of this project is to develop an improved RUTF treatment that addresses acute malnutrition and anemia in children, ensuring both safety and efficacy. Specifically, to assess the impact of malnutrition on fractional iron absorption (FIA) from RUTFs in children, by comparing healthy children to those with acute malnutrition and by tracking changes in FIA in malnourished children over the course of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy children | Active Comparator | Healthy children |
|
| Children with MAM/SAM | Experimental | children with moderate or severe acute malnutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron absorption from RUTF on Day 0 | Other | RUFT with 57Fe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fractional Iron Absorption | Day 0 | |
| Fractional Iron Absorption | Day 20 | |
| Fractional Iron Absorption | Day 40 | |
| Fractional Iron Absorption | Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Iron status parameter | Day 0 |
| Hemoglobin | Iron status parameter | Day 20 |
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Inclusion Criteria:
malnourished children:
healthy children:
- healthy: HAZ, WAZ and WHZ = 0
Exclusion Criteria (both groups):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suzane Nyilima, MSc | Contact | +254702836210 | suzane.nyilima@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ETH/Oxford/JKUAT research facility | Recruiting | Msambweni | Kwale County | Kenya |
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| Treatment with RUTF for 80 days | Dietary Supplement | Daily RUTF intake |
|
| Iron absorption from RUTF on Day 20 | Other | RUFT with 57Fe |
|
| Iron absorption from RUTF on Day 40 | Other | RUFT with 57Fe |
|
| Iron absorption from RUTF on Day 60 | Other | RUFT with 57Fe |
|
| Hemoglobin | Iron status parameter | Day 40 |
| Hemoglobin | Iron status parameter | Day 60 |
| Hemoglobin | Iron status parameter | Day 80 |
| Serum ferritin | Iron status parameter | Day 0 |
| Serum Ferritin | Iron status parameter | Day 20 |
| Serum Ferritin | Iron status parameter | Day 40 |
| Serum Ferritin | Iron status parameter | Day 60 |
| soluble transferrin receptor | Iron status parameter | Day 0 |
| soluble transferrin receptor | Iron status parameter | Day 20 |
| soluble transferrin receptor | Iron status parameter | Day 40 |
| soluble transferrin receptor | Iron status parameter | Day 60 |
| C-reactive protein | inflammation status parameter | Day 0 |
| C-reactive protein | inflammation status parameter | Day 20 |
| C-reactive protein | inflammation status parameter | Day 40 |
| C-reactive protein | inflammation status parameter | Day 60 |
| α₁-acid glycoprotein | inflammation status parameter | Day 0 |
| α₁-acid glycoprotein | inflammation status parameter | Day 20 |
| α₁-acid glycoprotein | inflammation status parameter | Day 40 |
| α₁-acid glycoprotein | inflammation status parameter | Day 60 |
| body weight | Day 0 |
| body weight | Day 20 |
| body weight | Day 40 |
| body weight | Day 60 |
| body height | Day 0 |
| body height | Day 20 |
| body height | Day 40 |
| body height | Day 60 |
| ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092 | Not yet recruiting | Zurich | 8006 | Switzerland |
|
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D015362 | Child Nutrition Disorders |
| D000740 | Anemia |
| D000067011 | Severe Acute Malnutrition |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009748 | Nutrition Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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