Clinical trial NCT03122938: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Iron-deficiency Anemia
Keywords: lactoferrin
Iron Metabolism
iron-deficiency anemia
pregnant women
fetal development
Lead sponsor: Beingmate Baby & Child Food Co Ltd .
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
First posted: 2017-04-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: iron-deficiency anemia morbility of pregnant women
timeFrame: every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
Secondary outcomes:
measure: iron metabolism of pregnant women
timeFrame: every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
measure: fetal growth
timeFrame: the day of delivery, recorded by nurse.
measure: fetal growth and development
timeFrame: the day of delivery,recorded by nurse immediately
measure: fetal development
timeFrame: the day of delivery, measured and recorded by nurse.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Fengbing Liang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: