Adiposity and Iron Requirements in Pregnancy
Recruiting now · Not applicable
Conditions studied: Iron Deficiency Anemia of Pregnancy
In brief
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.
Key facts
- Study ID
- NCT06425796
- Run by
- University of Ulster
- People needed
- 312
- Starts
- 2024-05-20
- Expected to finish
- 2027-03-19
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may not qualify if…
- 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
Where it is running
- Causeway Hospital — Coleraine, Co Londonderry, United Kingdom (enrolling)
- Causeway Hospital — Coleraine, Co. Londonderry, United Kingdom (enrolling)
- Ulster University,Human Intervention Studies Unit, — Coleraine, Co. Londonderry, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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