Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women

Iron-deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03122938
• Other study ID #: RD02914009A
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 20, 2016
• Last updated: April 20, 2017
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: April 2017
• Source: Beingmate Baby & Child Food Co Ltd .
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency Anemia

Intervention

Dietary Supplement:
• lactoferrin-supplemented formula
Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).
• formula without lactoferrin supplementation
Subjects consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) 3 times a day (81g totally).

Locations

Country	Name	City	State
China	Sir Run Run Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Beingmate Baby & Child Food Co Ltd .	Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	iron metabolism of pregnant women	hemoglobin concentration and serum ferritin concentration	every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
Secondary	fetal growth	body weight of newborns	the day of delivery, recorded by nurse.
Secondary	fetal growth and development	body length of newborns	the day of delivery,recorded by nurse immediately
Secondary	fetal development	head circumference	the day of delivery, measured and recorded by nurse.