Adiposity and Iron Requirements in Pregnancy

Iron Deficiency Anemia of Pregnancy Clinical Trial

— ADIPREG  

Official title:

Impact of Maternal Adiposity on Maternal Iron Status and Requirements: a Randomised Intervention Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425796
• Other study ID #: FCBMS-23-259
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: January 19, 2026

Study information

• Verified date: March 2024
• Source: University of Ulster
• Contact: Mary T McCann, PhD
• Phone: +4402870123969
• Email: mt.mccann[@]ulster.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 ≥ 18.5 kg/m2 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 312
• Est. completion date: January 19, 2026
• Est. primary completion date: January 19, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:- Pregnant women

• Age = 18 years
• BMI =18.5 kg/m2
• Without current pregnancy complications (for example, severe bleeding, Diabetes Mellitus, hyperemesis gravidarum, ectopic and molar pregnancies)
• At least 12 Gestational Week
• Singleton pregnancy confirmed with the first ultrasound scan
• Participants who are currently taking multivitamins will be included. They will be asked to discontinue any current supplementation.

Exclusion Criteria:

• Hb <110 g/L
• SF <30 µg/L
• High risk of iron overload (Hb >150 g/L, transferrin saturation >45% or SF> 150 µg/L)
• Participants with history of haematological, renal, liver, autoimmune disorders, malabsorptive syndromes
• Participants with history of bariatric surgery
• Participants who take steroids or anti-inflammatory treatments or drugs that affect gut absorption (proton-pump inhibitors)
• Planned home births
• Participants currently involved in another research study
• Multiple pregnancy
• Participants who do not speak English

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia of Pregnancy

Intervention

Dietary Supplement:
• Adiposity and Iron Requirements in Pregnancy (ADIPREG)
Iron 25 arm will receive: two iron supplements containing 12.5 mg of elemental iron + 1 multivitamin supplement (they will receive a total of 3 supplements per day). Iron 50 arm will receive: two 25 mg elemental iron supplements + 1 multivitamin supplement (they will receive a total of 3 supplements per day). The multivitamin supplement will contain folic acid, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, vitamin C and vitamin D. In summary, each participant will receive 3 supplements per day and instructed to take the 3 supplements together, in the morning, with breakfast. Supplements will be given to the participants when they attend for their clinic appointment. The intervention will begin at 12 gestational weeks and continue until the baby is delivered.

Locations

Country	Name	City	State
United Kingdom	Ulster University,Human Intervention Studies Unit,	Coleraine	Co. Londonderry

Sponsors (3)

Lead Sponsor	Collaborator
University of Ulster	Northern Health & Social Care Trust (NHSCT), Solvotrin Therapeutics - Active Iron

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted maternal ferritin concentrations in response to iron supplementation (ng/mL)	Assessed via ELISA analyses for ferritin concentration	16, 24 and 28 weeks after baseline
Secondary	Hemoglobin (g/L)	Assessed via Direct Current sheat flow method (Sysmex)	16, 24 and 28 weeks after baseline
Secondary	Red blood cell count (RBC) (10^12/L)	Assessed via Direct Current sheat flow method (Sysmex)	16, 24 and 28 weeks after baseline.
Secondary	Mean cell haemoglobin (MCH) (pg	Assessed via Direct Current sheat flow method (Sysmex)	16, 24 and 28 weeks after baseline.
Secondary	Mean cell volume (MCV) (fl)	Assessed via Direct Current sheat flow method (Sysmex)	16, 24 and 28 weeks after baseline.
Secondary	Mean cell haemoglobin concentrations (MCHC) (g/dL)	Assessed via Direct Current sheat flow method (Sysmex)	16, 24 and 28 weeks after baseline.
Secondary	Red cell distribution width (RDW) (%)	Assessed via Direct Current sheat flow method (Sysmex)	16, 24 and 28 weeks after baseline.
Secondary	Transferrin (g/L)	Assessed via immunoturbidimety assay	16, 24 and 28 weeks after baseline.
Secondary	Serum iron (umol/L)	Assessed via colorimetic assay	16, 24 and 28 weeks after baseline.
Secondary	sTfR (ug/mL)	Assessed via ELISA	16, 24 and 28 weeks after baseline.
Secondary	Hepcidin (pg/mL)	Assessed via ELISA	16, 24 and 28 weeks after baseline.
Secondary	C-reactive protein (mg/mL)	Assessed via ELISA	16, 24 and 28 weeks after baseline.
Secondary	Pro- anti- inflammatory biomarkers: IL-1 ß, IL-6, IL-10, IL-22, IL-17, TNF- a, IFN- ? (fg/mL)	Assessed via sandwich immunoassay	16, 24 and 28 weeks after baseline.
Secondary	Genetic variants of interest in relation to obesity and iron metabolism in response to iron supplementation.	Assessed via methylation analyses	16, 24 and 28 weeks after baseline.
Secondary	Mental health score in response to iron supplementation	CORE 10 questionnaire will be completed by each participant at each timepoint: CORE stands for "Clinical Outcomes in Routine Evaluation." The CORE-10 is a 10-item assesses psychological distress over the past week. The resulting score can be divided into categories with increasing severity: Healthy (0-5), low (6-10), mild (11-14), moderate (15-19), moderate-to-severe (20-24), and severe (25 and above). The score of this questionnaire will be collected as a numeric variable.	16, 24 and 28 weeks after baseline