Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Other: Standard infant fomula
* Other: Low level LF infant formula
* Other: High level LF infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term,healthy infants at 37-42 weeks of gestational age 5-9 months old infants were diagnose as iron deficiency anemia Accepting bottle feeding Exclusion Criteria: Hb<60 g/L Other microcytic, hypochromic anemia

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard infant fomula<br>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) | Other: Standard infant fomula<br>* 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.<br>|
| Experimental: Low level LF infant formula group<br>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 | Other: Low level LF infant formula<br>* 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).<br>|
| Experimental: High level LF infant formula group<br>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) | Other: High level LF infant formula<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |