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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03122938

Enrollment

120

Registered

2017-04-21

Start date

2016-04-30

Completion date

2017-05-31

Last updated

2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency Anemia

Keywords

lactoferrin, Iron Metabolism, iron-deficiency anemia, pregnant women, fetal development

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.

Interventions

DIETARY_SUPPLEMENTlactoferrin-supplemented formula

Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).

DIETARY_SUPPLEMENTformula without lactoferrin supplementation

Subjects consume formula without lactoferrin supplementation (\<6mg lactoferrin per 100g formula) 3 times a day (81g totally).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 34 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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	the day of delivery, recorded by nurse.	body weight of newborns
fetal growth and development	the day of delivery,recorded by nurse immediately	body length of newborns
fetal development	the day of delivery, measured and recorded by nurse.	head circumference

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026