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A multi-center,randomized,double-blind,controlled clinical trial was used to investigate the effectiveness of the treatment of infant iron deficiency anemia by taking ferralia and different contents lactoferrin.
5-9 months old infants with iron deficiency anemia were randomly divided into three groups. On the basis of giving the same dose of ferralia,three different levels lactoferrin infant formula were intervened 3 months respectively,and evaluate the clinical effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard infant fomula | Placebo Comparator | Infants with iron deficiency anemia randomly divided into this arm were given the same dose of ferralia with other arms,but were fed with standard infant formula (without lactoferrin supplementation) |
|
| Low level LF infant formula group | Experimental | Infants with iron deficiency anemia randomly divided into this arm were given the same dose of ferralia with other arms,but were fed with infant formula supplemented with low level of lactoferrin (38mg/100g). Lactoferrin:38mg/100g |
|
| High level LF infant formula group | Experimental | Infants with iron deficiency anemia randomly divided into this arm were given the same dose of ferralia with other arms,but were fed with infant formula supplemented with high level of lactoferrin (76mg/100g) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard infant fomula | Other | Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula without lactoferrin supplementation. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Hb concentration(g/L) | Hb was measured by the hemoglobincyanide method | Change of Hb concentration from baseline at 1 month and 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of body weight (kilograms) | Body weight is detected by electronic scale | Changes of body weight from baseline at 1 month and 3 months. |
| Change of body length (meters) | Body length is detected by infant height bed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Women's and Children's Central Hospital | Chengdu | China |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Low level LF infant formula | Other | Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula supplemented with low level of lactoferrin (38mg/100g). |
|
| High level LF infant formula | Other | Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula middle supplemented with high level of lactoferrin (76mg/100g). |
|
| Changes of body weight from baseline at 1 month and 3 months. |
| Change of head circumference (millimeters) | Head circumference detected by measuring tape | Changes of body weight from baseline at 1 month and 3 months. |
| Change of serum ferritin concentration (μg/L) | concentrations of serum ferritin (SF,μg/L) were measured using a commercial enzyme-linked immunosorbent assay (ELISA; Sunbiote, Shanghai, China). | Changes of serum iron concentration from baseline at 3 months. |
| Change of serum transferrin receptor concentration(mg/L) | Serum soluble transferrin receptor (sTfR, mg/L) was measured by microparticle-enhanced immunoassay (Sunbiote, Shanghai, China) | Changes of serum transferrin receptor concentration from baseline at 3 months. |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |