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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).
Subjects consume formula without lactoferrin supplementation (\<6mg lactoferrin per 100g formula) 3 times a day (81g totally).
Sir Run Run Hospital
Hangzhou, Zhejiang, China
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.
iron metabolism of pregnant women
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.
fetal growth
body weight of newborns
Time frame: the day of delivery, recorded by nurse.
fetal growth and development
body length of newborns
Time frame: the day of delivery,recorded by nurse immediately
fetal development
head circumference
Time frame: the day of delivery, measured and recorded by nurse.
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