Iron-deficiencyNCT04699045
Prenatal Iron Status and Its Association With Cord Blood and Infant Ferritin Level
An observational study of Iron-deficiency, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- No active intervention
- How many people
- 97 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Iron-deficiency
- Being tested
- No active intervention
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No active interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferritin concentrations
Ferritin concentrations in late pregnancy, in cord blood and in early infancy
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study startJan 2014
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Ching Ching Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699045
- Sponsor's protocol ID
- Ferritin_cohort
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Iron Status and Its Association With Cord Blood and Infant Ferritin Level
- ClinicalTrials.gov ID
- NCT04699045
- Acronym / sponsor ID
- Ferritin_cohort
- Conditions
- Iron-deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No active intervention | Other | – |
Primary outcome
Ferritin concentrations
Time frame: up to 3 months
Ferritin concentrations in late pregnancy, in cord blood and in early infancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Iron-deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron-deficiency, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferritin concentrations (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.