Back to resultsEffectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standard infant fomula
Low level LF infant formula
High level LF infant formula
Sponsored by
About this trial
This is an interventional basic science trial for Iron Deficiency Anemia
Eligibility 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
Sites / Locations
- Chengdu Women's and Children's Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Standard infant fomula
Low level LF infant formula group
High level LF infant formula group
Arm 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)
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
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)
Outcomes
Primary Outcome Measures
Changes of Hb concentration(g/L)
Hb was measured by the hemoglobincyanide method
Secondary Outcome Measures
Change of body weight (kilograms)
Body weight is detected by electronic scale
Change of body length (meters)
Body length is detected by infant height bed
Change of head circumference (millimeters)
Head circumference detected by measuring tape
Change of serum ferritin concentration (μg/L)
concentrations of serum ferritin (SF,μg/L) were measured using a commercial enzyme-linked immunosorbent assay (ELISA; Sunbiote, Shanghai, China).
Change of serum transferrin receptor concentration(mg/L)
Serum soluble transferrin receptor (sTfR, mg/L) was measured by microparticle-enhanced immunoassay (Sunbiote, Shanghai, China)
Full Information
NCT ID
NCT03534089
First Posted
April 27, 2018
Last Updated
May 22, 2018
Sponsor
Beingmate Baby & Child Food Co Ltd .
1. Study Identification
Unique Protocol Identification Number
NCT03534089
Brief Title
Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
Official Title
Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beingmate Baby & Child Food Co Ltd .
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard infant fomula
Arm Type
Placebo Comparator
Arm 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)
Arm Title
Low level LF infant formula group
Arm Type
Experimental
Arm 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
Arm Title
High level LF infant formula group
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
Standard infant fomula
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low level LF infant formula
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
High level LF infant formula
Intervention Description
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 Outcome Measure Information:
Title
Changes of Hb concentration(g/L)
Description
Hb was measured by the hemoglobincyanide method
Time Frame
Change of Hb concentration from baseline at 1 month and 3 months.
Secondary Outcome Measure Information:
Title
Change of body weight (kilograms)
Description
Body weight is detected by electronic scale
Time Frame
Changes of body weight from baseline at 1 month and 3 months.
Title
Change of body length (meters)
Description
Body length is detected by infant height bed
Time Frame
Changes of body weight from baseline at 1 month and 3 months.
Title
Change of head circumference (millimeters)
Description
Head circumference detected by measuring tape
Time Frame
Changes of body weight from baseline at 1 month and 3 months.
Title
Change of serum ferritin concentration (μg/L)
Description
concentrations of serum ferritin (SF,μg/L) were measured using a commercial enzyme-linked immunosorbent assay (ELISA; Sunbiote, Shanghai, China).
Time Frame
Changes of serum iron concentration from baseline at 3 months.
Title
Change of serum transferrin receptor concentration(mg/L)
Description
Serum soluble transferrin receptor (sTfR, mg/L) was measured by microparticle-enhanced immunoassay (Sunbiote, Shanghai, China)
Time Frame
Changes of serum transferrin receptor concentration from baseline at 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chengdu Women's and Children's Central Hospital
City
Chengdu
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
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