- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04699045
Prenatal Iron Status and Its Association With Cord Blood and Infant Ferritin Level
Study Overview
Detailed Description
Iron deficiency (ID) is the most common micronutrient deficiency globally. Pregnant women and young children are at risk of ID. During pregnancy, there is an increased demand for iron to accommodate the needs of the fetal-placental unit. This increase in physiologic demand for iron renders pregnant women vulnerable to ID. In fact, ID is the major cause of anemia in pregnancy and can increase the perinatal maternal morbidity and mortality. Iron is also an essential micronutrient for fetal and infant brain development. ID in early life is associated with worse cognitive, motor, social emotional as well as neurophysiological development. Besides neurodevelopment, iron is also essential for proper immune function affecting both innate and adaptive cell, and has implications for childhood atopic diseases.
Globally, there is an increasing trend of breastfeeding especially in developed countries.In Hong Kong, the government's continuing effort to promote breastfeeding has successfully boosted the rate of babies being breastfed. This encouraging information means more children will benefit from the many advantages of breast milk over formula milk, yet exclusive breastfeeding, particularly in the context of maternal ID and late weaning, may be a risk factor of ID in the infants. In view of the adverse impact of fetal and infant ID on neurocognitive development, it is important to evaluate the iron status of young infants, the effect of feeding practices on development of ID and the risk factors of ID in early infancy.
Maternal ID is prevalent worldwide varying from 20% to 90%. Previous investigation performed in the Department of Obstetrics and Gynaecology, Prince of Wales Hospital, concurred a significant prevalence (39%) of ID (serum ferritin < 15 microgram/L) among 100 asymptomatic pregnant women. Most fetal iron needed for infant growth is acquired in the third trimester from maternal iron store, in preparation for the high growth rate in the first 6 months of life. Iron status at birth is therefore critical and impaired iron status may persist into early childhood. However, low maternal prenatal iron levels measured as serum ferritin have not been consistently linked with low cord blood serum ferritin (CBSF) concentrations. Some studies reported that there was no correlation between serum ferritin of mothers and babies. However, others found that maternal ID or anemia, especially the severe type, adversely affected cord blood or infant iron status. Further studies are needed to evaluate how prenatal maternal iron status affects newborn's ferritin level at birth. Such data is necessary to guide future recommendations regarding the need of iron supplement in pregnant or lactating women and/or their infants. Hence, this study aimed to examine the associations between maternal prenatal ferritin levels with CBSF and to compare the ferritin levels with different feeding practices in early infancy at 3 months of age.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ferritin concentrations
Time Frame: up to 3 months
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Ferritin concentrations in late pregnancy, in cord blood and in early infancy
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up to 3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ferritin_cohort
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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