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Completed

NCT Number: NCT03534089

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

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 month–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chengdu Women's and Children's Central Hospital

Chengdu, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard infant fomula

Other

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

Other

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

Other

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).

Primary outcomes

  1. Changes of Hb concentration(g/L)

    Time frame: Change of Hb concentration from baseline at 1 month and 3 months.

    Hb was measured by the hemoglobincyanide method

Secondary outcomes

  1. Change of body weight (kilograms)

    Time frame: Changes of body weight from baseline at 1 month and 3 months.

    Body weight is detected by electronic scale

  2. Change of body length (meters)

    Time frame: Changes of body weight from baseline at 1 month and 3 months.

    Body length is detected by infant height bed

  3. Change of head circumference (millimeters)

    Time frame: Changes of body weight from baseline at 1 month and 3 months.

    Head circumference detected by measuring tape

  4. Change of serum ferritin concentration (μg/L)

    Time frame: 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).

  5. Change of serum transferrin receptor concentration(mg/L)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Beingmate Baby & Child Food Co Ltd .

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 23, 2018
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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