Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425796
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-09
Brief Title:
Adiposity and Iron Requirements in Pregnancy
Sponsor:
University of Ulster
Organization:
University of Ulster
Study Overview
Official Title:
Impact of Maternal Adiposity on Maternal Iron Status and Requirements a Randomised Intervention Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADIPREG
Brief Summary:
This study aims to explore how body fat influences the response to either 25 or 50 mg of daily iron supplements during pregnancy We will conduct a double-blind randomized controlled intervention study involving 312 pregnant women recruited from antenatal clinics in the Northern Trust Area Participants will be randomly assigned to receive either 25 or 50 mg of iron per day from 12 weeks of pregnancy until delivery using the Active Iron supplement brand Blood samples will be collected at 12 28 and 36 weeks gestation and umbilical cord blood will be collected at delivery Anthropometric measurements will be taken at each visit and participants will complete questionnaires on various aspects of health and lifestyle mental health gastrointestinal symptoms and compliance
Detailed Description:
The main aim of this study is to investigate the influence of adiposity on the difference in response to 25 or 50 mg of daily iron supplementation during pregnancy The primary aim is to determine the influence of maternal adiposity on adjusted maternal ferritin concentrations in response to 25 mg or 50 mg iron supplementation in pregnancy The secondary outcomes of this study include investigating the impact of maternal body fat on various maternal iron biomarkers such as haemoglobin soluble transferrin receptor hepcidin transferrin saturation and other haematological markers in response to either 25 mg or 50 mg iron supplementation during pregnancy evaluating changes in adjusted ferritin concentrations and other iron markers throughout pregnancy relative to the dosage of iron supplementation received determining the effect of maternal body fat on neonatal iron biomarkers in response to maternal iron supplementation assessing changes in markers of inflammation in response to iron supplementation during pregnancy and examine changes in mental health scores in response to iron supplementation during pregnancy
This is a double-blind randomised controlled intervention study in which 312 pregnant women with singleton pregnancy without current complications aged 18 years and BMI 185 kgm2 will be recruited Participants who are taking multivitamins will be included They will be asked to discontinue any current supplementation Pregnant women with anaemia iron deficiency high risk of iron overload history of bariatric surgery who are planning home birth are currently involved in another research study and those who cannot speak or understand English language will be excluded
Blood samples and anthropometric and body composition measurements will be taken at different points in the pregnancy 12 28 36 gestational weeks and an umbilical cord blood sample at the time of birth Blood concentrations of iron and inflammation markers will be analysed General dietary intake and lifestyle information will be collected through a Health and Lifestyle questionnaire and a 4-day diary Additionally participants will complete a questionnaire about their mental health and gastrointestinal symptoms The compliance of the supplementation will be evaluated at each timepoint Additionally participants will receive a telephone call to evaluate possible adverse effects and compliance of the supplementation between the timepoints 18 24 and 32 weeks of gestation In the event that a participant has been prescribed iron treatment anaemia diagnosis at any time during pregnancy or the occurrence of any adverse outcome such as miscarriage the participant will be withdrawn from the study Electronic forms prepared in RedCap will be used to collect data
This is a double-blind randomised controlled intervention study in which 312 pregnant women with singleton pregnancy without current complications aged 18 years and BMI 185 kgm2 will be recruited Participants who are taking multivitamins will be included They will be asked to discontinue any current supplementation Pregnant women with anaemia iron deficiency high risk of iron overload history of bariatric surgery who are planning home birth are currently involved in another research study and those who cannot speak or understand English language will be excluded
Blood samples and anthropometric and body composition measurements will be taken at different points in the pregnancy 12 28 36 gestational weeks and an umbilical cord blood sample at the time of birth Blood concentrations of iron and inflammation markers will be analysed General dietary intake and lifestyle information will be collected through a Health and Lifestyle questionnaire and a 4-day diary Additionally participants will complete a questionnaire about their mental health and gastrointestinal symptoms The compliance of the supplementation will be evaluated at each timepoint Additionally participants will receive a telephone call to evaluate possible adverse effects and compliance of the supplementation between the timepoints 18 24 and 32 weeks of gestation In the event that a participant has been prescribed iron treatment anaemia diagnosis at any time during pregnancy or the occurrence of any adverse outcome such as miscarriage the participant will be withdrawn from the study Electronic forms prepared in RedCap will be used to collect data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None