Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women

Not Applicable

• Conditions: Iron-deficiency Anemia
• Interventions: Dietary Supplement: lactoferrin-supplemented formula; Dietary Supplement: formula without lactoferrin supplementation

• Registration Number: NCT03122938
• Lead Sponsor: Beingmate Baby & Child Food Co Ltd .

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-08-20
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study First Submitted QC: 2017-04-20
• Last Update Submitted: 2017-04-20
• Study First Posted: 2017-04-21
• Last Update Posted: 2017-04-21
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactoferrin Group	lactoferrin-supplemented formula	lactoferrin-supplemented formula
Control Group	formula without lactoferrin supplementation	formula without lactoferrin supplementation

Primary Outcome Measures

Name	Time	Method
iron-deficiency anemia morbility of pregnant women	every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.

Secondary Outcome Measures

Name	Time	Method
fetal development	the day of delivery, measured and recorded by nurse.	head circumference
iron metabolism of pregnant women	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
fetal growth and development	the day of delivery,recorded by nurse immediately	body length of newborns
fetal growth	the day of delivery, recorded by nurse.	body weight of newborns

Trial Locations

Locations (1)

Sir Run Run Hospital; 🇨🇳 Hangzhou, Zhejiang, China