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

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia

• Registration Number: NCT03534089
• Lead Sponsor: Beingmate Baby & Child Food Co Ltd .

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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2017-12
• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2018-05-22
• Last Update Submitted: 2018-05-22
• Study First Posted: 2018-05-23
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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 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 body weight (kilograms)	Changes of body weight from baseline at 1 month and 3 months.	Body weight is detected by electronic scale

Trial Locations

Locations (1)

Chengdu Women's and Children's Central Hospital; 🇨🇳 Chengdu, China