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| Name | Class |
|---|---|
| Nutreva S.A.S. | UNKNOWN |
| Foundation Child Care - FAN | OTHER |
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Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. This condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide.
Food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. It is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of Medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate.
It is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous sulphate | Active Comparator | Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin, which will be supplied with ferrous sulfate-fortified milk |
|
| Iron Amino acid chelate | Experimental | Preschool children with depleted levels of iron enrolled in FAN Foundation of Medellin , which will be supplied with iron amino acid chelate-fortified milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous sulfate as dietary supplementation | Other | Ferrous sulfate as dietary supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin | The Ferritin level in blood will be measured at the beginning of the study as one of the most important inclusion criteria. This also will be the base line of the study. After that randomization will be carried out and after two months (time frame which ferrous sulfate or iron aminoacid chelate would increase ferritin level in blood) ferritin level will be measured again as the primary outcome measure. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | The Hemoglobin level in blood will be measured at the beginning of the study as one of the most important exclusion criteria. After that randomization will be carried out and after two months (time frame which ferrous sulfate or iron aminoacid chelate would increase ferritin level in blood) hemoglobin level will be measured again as one of secundary outcome measure. The hypothesis is that the hemoglobin level won't decrease |
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Inclusion Criteria:
Children who
Exclusion Criteria:
Children who
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| Name | Affiliation | Role |
|---|---|---|
| Ana M Herrera, PhD en PatologÃa | CES University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad CES | MedellÃn | Antioquia | Colombia |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Iron amino acid chelated as dietary supplementation | Other | Iron amino acid chelated as dietary supplementation |
|
| Up to 8 weeks |
| Infection | Daily written report of the caregiver during the intervention | Daily. During 2 months of intervention |
| Adverse reaction | The caregiver recorded daily if the child had an adverse reaction such as abdominal pain, nausea, vomiting, constipation, diarrhea, darkening of feces, and disgust for food. | Daily. During 2 months of intervention |