Lactoferrin Supplementation and Iron Metabolism in Healthy Pregnant Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Iron-deficiency Anemia

Intervention / Treatment
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* Dietary Supplement: lactoferrin-supplemented formula
* Dietary Supplement: formula without lactoferrin supplementation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactoferrin Group<br>lactoferrin-supplemented formula | Dietary Supplement: lactoferrin-supplemented formula<br>* Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).<br>* Other names: Beingmate Nursing Mommy Formula;|
| Placebo Comparator: Control Group<br>formula without lactoferrin supplementation | Dietary Supplement: formula without lactoferrin supplementation<br>* Subjects consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) 3 times a day (81g totally).<br>* Other names: Beingmate Nursing Mommy Formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactoferrin, Iron Metabolism, iron-deficiency anemia, pregnant women, fetal development