Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Iron-deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactoferrin Group

lactoferrin-supplemented formula

Group Type EXPERIMENTAL

lactoferrin-supplemented formula

Intervention Type DIETARY_SUPPLEMENT

Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).

Control Group

formula without lactoferrin supplementation

Group Type PLACEBO_COMPARATOR

formula without lactoferrin supplementation

Intervention Type DIETARY_SUPPLEMENT

Subjects consume formula without lactoferrin supplementation (\<6mg lactoferrin per 100g formula) 3 times a day (81g totally).

Interventions

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lactoferrin-supplemented formula

Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).

Intervention Type DIETARY_SUPPLEMENT

formula without lactoferrin supplementation

Subjects consume formula without lactoferrin supplementation (\<6mg lactoferrin per 100g formula) 3 times a day (81g totally).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Beingmate Nursing Mommy Formula Beingmate Nursing Mommy Formula

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes