Iron Deficiency Anemia
Conditions
Brief summary
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
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.
Interventions
OTHERStandard infant fomula
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.
OTHERLow level LF infant formula
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).
OTHERHigh level LF infant formula
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).
Sponsors
Beingmate Baby & Child Food Co Ltd .
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Months to 9 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Hb concentration(g/L) | Change of Hb concentration from baseline at 1 month and 3 months. | Hb was measured by the hemoglobincyanide method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of body weight (kilograms) | Changes of body weight from baseline at 1 month and 3 months. | Body weight is detected by electronic scale |
| Change of body length (meters) | Changes of body weight from baseline at 1 month and 3 months. | Body length is detected by infant height bed |
| Change of head circumference (millimeters) | Changes of body weight from baseline at 1 month and 3 months. | Head circumference detected by measuring tape |
| Change of serum ferritin concentration (μg/L) | Changes of serum iron concentration from baseline at 3 months. | concentrations of serum ferritin (SF,μg/L) were measured using a commercial enzyme-linked immunosorbent assay (ELISA; Sunbiote, Shanghai, China). |
| Change of serum transferrin receptor concentration(mg/L) | Changes of serum transferrin receptor concentration from baseline at 3 months. | Serum soluble transferrin receptor (sTfR, mg/L) was measured by microparticle-enhanced immunoassay (Sunbiote, Shanghai, China) |
Countries
China
Outcome results
None listed