NCT03122938

Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Beingmate Baby & Child Food Co Ltd . · Academic / Other
• Sex: Female
• Age: 20 Years – 34 Years
• Healthy volunteers: Accepted

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.

Conditions

• Iron-deficiency Anemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	lactoferrin-supplemented formula	Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).
DIETARY_SUPPLEMENT	formula without lactoferrin supplementation	Subjects consume formula without lactoferrin supplementation (\<6mg lactoferrin per 100g formula) 3 times a day (81g totally).

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2017-04-21
• Last updated: 2017-04-21

Locations

1 site across 1 country: China