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Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women

Primary Purpose

Iron-deficiency Anemia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
lactoferrin-supplemented formula
formula without lactoferrin supplementation
Sponsored by
Beingmate Baby & Child Food Co Ltd .
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron-deficiency Anemia focused on measuring lactoferrin, Iron Metabolism, iron-deficiency anemia, pregnant women, fetal development

Eligibility Criteria

20 Years - 34 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy pregnant women with gestational weeks between 24 and 26;
  • with hemoglobin concentration > 110g / L;
  • without indication of abortion;
  • without infectious disease or hereditary disease;
  • without iron supplementation before enrollment.

Exclusion Criteria:

  • with red blood count <3.5*10^12/L，hemoglobin concentration<110g/L or serum ferritin <20 μg/L；
  • diagnosed with gestational diabetes mellitus;
  • enrolled in other intervention study within past 1 month.

Sites / Locations

  • Sir Run Run Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactoferrin Group

Control Group

Arm Description

lactoferrin-supplemented formula

formula without lactoferrin supplementation

Outcomes

Primary Outcome Measures

iron-deficiency anemia morbility of pregnant women

Secondary Outcome Measures

iron metabolism of pregnant women
hemoglobin concentration and serum ferritin concentration
fetal growth
body weight of newborns
fetal growth and development
body length of newborns
fetal development
head circumference

Full Information

First Posted
August 20, 2016
Last Updated
April 20, 2017
Sponsor
Beingmate Baby & Child Food Co Ltd .
Collaborators
Sir Run Run Shaw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03122938
Brief Title
Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women
Official Title
Effect of Daily Bovine Lactoferrin Supplementation on Fetal Development and Iron Metabolism in Healthy Pregnant Women: A Randomized Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beingmate Baby & Child Food Co Ltd .
Collaborators
Sir Run Run Shaw Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the effects of a lactoferrin supplemented formula on fetal development , iron metabolism and immunity in healthy pregnant women. One hundred and twenty healthy pregnant women (24<gestational weeks<26) are enrolled and randomly assigned to lactoferrin-supplemented formula group (active group) or normal formula group (control group, without lactoferrin supplementation). Subjects allocated in active group consume lactoferrin supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally), while those in control group consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) according to the same schedule. Routine blood test including hemoglobin and serum ferritin, and food frequency questionnaire-based review and 24h*3 dietary record are performed every 4 weeks during intervention until delivery. Body weight of newborns are recorded after delivery. The differences in iron deficiency anemia morbility of pregnant women and anthropometric measurements of newborns between groups would be analyzed after completion of this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency Anemia
Keywords
lactoferrin, Iron Metabolism, iron-deficiency anemia, pregnant women, fetal development

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactoferrin Group
Arm Type
Experimental
Arm Description
lactoferrin-supplemented formula
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
formula without lactoferrin supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
lactoferrin-supplemented formula
Other Intervention Name(s)
Beingmate Nursing Mommy Formula
Intervention Description
Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).
Intervention Type
Dietary Supplement
Intervention Name(s)
formula without lactoferrin supplementation
Other Intervention Name(s)
Beingmate Nursing Mommy Formula
Intervention Description
Subjects consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) 3 times a day (81g totally).
Primary Outcome Measure Information:
Title
iron-deficiency anemia morbility of pregnant women
Time Frame
every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
Secondary Outcome Measure Information:
Title
iron metabolism of pregnant women
Description
hemoglobin concentration and serum ferritin concentration
Time Frame
every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
Title
fetal growth
Description
body weight of newborns
Time Frame
the day of delivery, recorded by nurse.
Title
fetal growth and development
Description
body length of newborns
Time Frame
the day of delivery,recorded by nurse immediately
Title
fetal development
Description
head circumference
Time Frame
the day of delivery, measured and recorded by nurse.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy pregnant women with gestational weeks between 24 and 26; with hemoglobin concentration > 110g / L; without indication of abortion; without infectious disease or hereditary disease; without iron supplementation before enrollment. Exclusion Criteria: with red blood count <3.5*10^12/L，hemoglobin concentration<110g/L or serum ferritin <20 μg/L； diagnosed with gestational diabetes mellitus; enrolled in other intervention study within past 1 month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengbing Liang, Ph.D
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Run Run Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Available when oversight authorities require.

Learn more about this trial

Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women

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