About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Adiposity and Iron Requirements in Pregnancy (ADIPREG)
Treatment groups
Sponsors and collaborators
University of Ulster
Lead sponsor
Solvotrin Therapeutics - Active Iron
Collaborator
National Health Service, United Kingdom
Collaborator