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

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Other: Standard infant fomula; Other: Low level LF infant formula; Other: High level LF infant formula

• 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

Arm && Interventions

Group	Intervention	Description
Standard infant fomula	Standard infant fomula	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	Low level LF infant formula	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	High level LF infant formula	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)

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