NCT03534089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
Last Updated

May 23, 2018

Status Verified

December 1, 2017

Enrollment Period

9 months

First QC Date

April 27, 2018

Last Update Submit

May 22, 2018

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Changes of Hb concentration(g/L)

    Hb was measured by the hemoglobincyanide method

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

Secondary Outcomes (5)

  • Change of body weight (kilograms)

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

  • Change of body length (meters)

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

  • Change of head circumference (millimeters)

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

  • Change of serum ferritin concentration (μg/L)

    Changes of serum iron concentration from baseline at 3 months.

  • Change of serum transferrin receptor concentration(mg/L)

    Changes of serum transferrin receptor concentration from baseline at 3 months.

Study Arms (3)

Standard infant fomula

PLACEBO COMPARATOR

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

Low level LF infant formula group

EXPERIMENTAL

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

High level LF infant formula group

EXPERIMENTAL

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

Interventions

Standard infant fomulaOTHER

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.

Standard infant fomula
Low level LF infant formulaOTHER

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).

Low level LF infant formula group
High level LF infant formulaOTHER

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).

High level LF infant formula group

Eligibility Criteria

Age5 Months - 9 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Full term,healthy infants at 37-42 weeks of gestational age
  • months old infants were diagnose as iron deficiency anemia
  • Accepting bottle feeding

You may not qualify if:

  • Hb\<60 g/L
  • Other microcytic, hypochromic anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu Women's and Children's Central Hospital

Chengdu, China

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 23, 2018

Study Start

February 1, 2017

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

May 23, 2018

Record last verified: 2017-12

Locations

CN(1)