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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03534089
• Other study ID #: RD07316001A
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: December 2017
• Source: Beingmate Baby & Child Food Co Ltd .
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Months to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Other:
• Standard 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.
• Low 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).
• High 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).

Locations

Country	Name	City	State
China	Chengdu Women's and Children's Central Hospital	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
Beingmate Baby & Child Food Co Ltd .

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of body weight (kilograms)	Body weight is detected by electronic scale	Changes of body weight from baseline at 1 month and 3 months.
Secondary	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.
Secondary	Change of head circumference (millimeters)	Head circumference detected by measuring tape	Changes of body weight from baseline at 1 month and 3 months.
Secondary	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.
Secondary	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.