NCT03122938

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

August 20, 2016

Last Update Submit

April 20, 2017

Conditions

Iron-deficiency Anemia

Keywords

lactoferrinIron Metabolismiron-deficiency anemiapregnant womenfetal development

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

  • fetal growth

    the day of delivery, recorded by nurse.

  • fetal growth and development

    the day of delivery,recorded by nurse immediately

  • fetal development

    the day of delivery, measured and recorded by nurse.

Study Arms (2)

Lactoferrin Group

EXPERIMENTAL

lactoferrin-supplemented formula

Dietary Supplement: lactoferrin-supplemented formula

Control Group

PLACEBO COMPARATOR

formula without lactoferrin supplementation

Dietary Supplement: formula without lactoferrin supplementation

Interventions

lactoferrin-supplemented formulaDIETARY_SUPPLEMENT

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

Also known as: Beingmate Nursing Mommy Formula
Lactoferrin Group
formula without lactoferrin supplementationDIETARY_SUPPLEMENT

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

Also known as: Beingmate Nursing Mommy Formula
Control Group

Eligibility Criteria

Age20 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Foods, SpecializedFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Fengbing Liang, Ph.D

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2016

First Posted

April 21, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

April 21, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Available when oversight authorities require.

Locations

CN(1)