Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women

April 20, 2017 updated by: Beingmate Baby & Child Food Co Ltd .

Effect of Daily Bovine Lactoferrin Supplementation on Fetal Development and Iron Metabolism in Healthy Pregnant Women: A Randomized Double-blind Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Sir Run Run Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 34 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lactoferrin Group
lactoferrin-supplemented formula
Dietary supplement: lactoferrin-supplemented formula
Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).
Other Names:
  • Beingmate Nursing Mommy Formula
PLACEBO_COMPARATOR: Control Group
formula without lactoferrin supplementation
Dietary supplement: formula without lactoferrin supplementation
Subjects consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) 3 times a day (81g totally).
Other Names:
  • Beingmate Nursing Mommy Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iron metabolism 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.
hemoglobin concentration and serum ferritin concentration
every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
fetal growth
Time Frame: the day of delivery, recorded by nurse.
body weight of newborns
the day of delivery, recorded by nurse.
fetal growth and development
Time Frame: the day of delivery,recorded by nurse immediately
body length of newborns
the day of delivery,recorded by nurse immediately
fetal development
Time Frame: the day of delivery, measured and recorded by nurse.
head circumference
the day of delivery, measured and recorded by nurse.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beingmate Baby & Child Food Co Ltd .

Collaborators

Sir Run Run Shaw Hospital

Investigators

  • Principal Investigator: Fengbing Liang, Ph.D, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

August 20, 2016

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD02914009A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Available when oversight authorities require.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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