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

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ClinicalTrials.gov Identifier: NCT03534089
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Beingmate Baby & Child Food Co Ltd .

Study Description
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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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Other: Standard infant fomula Other: Low level LF infant formula Other: High level LF infant formula Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 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)
 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.
Experimental: Low level LF infant formula group
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
 Other: 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).
Experimental: High level LF infant formula group
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)
 Other: 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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   5 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534089


Locations
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China
Chengdu Women's and Children's Central Hospital
Chengdu, China
Sponsors and Collaborators
Beingmate Baby & Child Food Co Ltd .
More Information
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Responsible Party: Beingmate Baby & Child Food Co Ltd .
ClinicalTrials.gov Identifier: NCT03534089    
Other Study ID Numbers: RD07316001A
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
 Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders