NCT06425796Recruiting
Adiposity and Iron Requirements in Pregnancy
Impact of Maternal Adiposity on Maternal Iron Status and Requirements: a Randomised Intervention Study
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 9 May 2024
- Start date
- 20 May 2024
- Primary completion date
- 19 Jan 2027
- Lead sponsor
- University of Ulster
- Diseases
- Obesity
- NCT number
- NCT06425796
What you commit to
- Study type: Interventional
- Planned participants: 312
- From 20 May 2024 to the primary completion date, 19 Jan 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who take steroids or anti-inflammatory treatments or drugs that affect gut absorption (proton-pump inhibitors)
Other illness
- Participants with history of haematological, renal, liver, autoimmune disorders, malabsorptive syndromes
- Participants with history of bariatric surgery
Lab values
- 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)
Other
- Planned home births
- Participants currently involved in another research study
- Multiple pregnancy
- Participants who do not speak English
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Causeway Hospital Coordinator of this site? Confirm its status | Coleraine | United Kingdom | Recruiting |
| Ulster University, Human Intervention Studies Unit Coordinator of this site? Confirm its status | Coleraine | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.