NCT04699045

Brief Summary

Iron deficiency (ID) in early life is associated with significant morbidities. Most fetal iron required for infant growth is acquired in the third trimester from maternal iron store. However, how prenatal iron level affects newborn's ferritin level at birth and in early infancy remains controversial. This study aimed to examine the associations between maternal ferritin levels with cord blood serum ferritin (CBSF) and to compare the ferritin levels between different feeding practices in early infancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 6, 2021

Last Update Submit

January 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ferritin concentrations

    Ferritin concentrations in late pregnancy, in cord blood and in early infancy

    up to 3 months

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Chinese mothers with uncomplicated pregnancy were recruited from a cohort which was established to evaluate gestational age specific thyroid function during pregnancy. Between July 2014 and January 2016, pregnant women attended antenatal care in their first trimester of pregnancy were recruited by research personnel in the antenatal clinic at the Prince of Wales Hospital, which is a tertiary teaching hospital in Hong Kong. After delivery, mothers were again approached and invited to join this study by research personnel in the postnatal ward.

You may qualify if:

  • Women who carried a singleton pregnancy without any history of thyroid dysfunction, hyperemesis gravidarum, autoimmune disease, or any other major medical condition with cord blood available were eligible for this study

You may not qualify if:

  • multiple pregnancy, preterm delivery at less than 37 weeks of gestation, infants with congenital anomalies, syndromal diseases, chronic renal or hepatic diseases, metabolic disease, chronic gastrointestinal diseases and/or malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professional Consultant

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 7, 2021

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations