Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04699045
Other study ID # Ferritin_cohort
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date July 2016

Study information

Verified date January 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date July 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No active intervention


Locations

Country Name City State
Hong Kong Prince of Wales Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ferritin concentrations Ferritin concentrations in late pregnancy, in cord blood and in early infancy up to 3 months
See also
  Status Clinical Trial Phase
Completed NCT04949165 - Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study N/A
Terminated NCT03218384 - Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency Phase 2
Active, not recruiting NCT03516734 - Iron-fortified Lentils to Improve Iron (Fe) Status in Bangladesh N/A
Completed NCT03572010 - Stable Iron Isotope Method in HIV+ and HIV- Children N/A
Active, not recruiting NCT03703726 - Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures. N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Not yet recruiting NCT05395468 - Diagnosis of Iron Deficiency by Artificial Intelligence Analysis of Eye Photography.
Withdrawn NCT03800446 - Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood N/A
Not yet recruiting NCT03353662 - Sub Regional Micronutrient Survey in Ethiopia
Completed NCT03819530 - Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study N/A
Recruiting NCT04144790 - Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Completed NCT03957057 - Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia Phase 3
Completed NCT03642223 - Central and Peripheral Adiposity and Iron Absorption N/A
Not yet recruiting NCT05407987 - Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) Phase 3
Withdrawn NCT03873584 - Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
Enrolling by invitation NCT03897673 - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas N/A
Completed NCT04359368 - Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Enrolling by invitation NCT05750940 - Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
Recruiting NCT05126901 - Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years Phase 3