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

Beingmate Baby & Child Food

Status: Completed

Conditions: Iron Deficiency Anemia

Treatments: Other: High level LF infant formula; Other: Low level LF infant formula; Other: Standard infant fomula

Study type: Interventional

Funder types: Other

Identifiers

NCT03534089

RD07316001A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 5 to 9 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 3 patient groups, including a placebo group

Standard infant fomula

Placebo Comparator group

Description:

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)

Treatment:

Other: Standard infant fomula

Low level LF infant formula group

Experimental group

Description:

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

Treatment:

Other: Low level LF infant formula

High level LF infant formula group

Experimental group

Description:

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)

Treatment:

Other: High level LF infant formula