Adiposity and Iron Requirements in Pregnancy
Recruiting · NCT06425796 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Ulster
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
3 locations listed.
- Causeway Hospital - Coleraine, Co Londonderry, United Kingdom
- Causeway Hospital - Coleraine, Co. Londonderry, United Kingdom
- Ulster University,Human Intervention Studies Unit, - Coleraine, Co. Londonderry, United Kingdom