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Testing two iron doses in pregnant women with different body fat

Compares 25 mg and 50 mg daily iron in pregnant women with varying body fat.

Plain-language title generated from the registry record
Registry title: Adiposity and Iron Requirements in Pregnancy

Key facts

Where
Coleraine, United KingdomSee the 2 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for pregnant women aged 18 or older, at least 12 weeks pregnant, with one baby and no pregnancy complications. They take 25 or 50 mg of iron daily until delivery.

Age
18 years or older
Sex
Women only
Disease stage
Pregnant for at least 12 weeks, with one baby confirmed by the first ultrasound scan, and no current pregnancy complications such as severe bleeding, diabetes, hyperemesis gravidarum, or ectopic and molar pregnancies.
Earlier treatment
People taking multivitamins can join but are asked to stop any current supplements. People taking steroids, anti-inflammatory treatments or drugs that affect gut absorption (proton-pump inhibitors) cannot join.
Biomarker or test result
BMI of 18.5 kg/m2 or more. Haemoglobin (Hb) must not be below 110 g/L. Ferritin (SF) must not be below 30 μg/L.

Main reasons for not taking part

  • Multiple pregnancy
  • High risk of iron overload (Hb >150 g/L, transferrin saturation >45% or SF >150 μg/L)
  • History of blood, kidney, liver or autoimmune disorders, or malabsorptive syndromes
  • History of bariatric surgery
  • Planned home birth, another research study at the same time, or not speaking English

This trial only enrols pregnant participants. The registry sentence this rests on: Inclusion Criteria:- Pregnant women

Read by machine on 9 November 2026.

Where in United Kingdom

  • Causeway HospitalColeraine, United KingdomTaking people
  • Ulster University, Human Intervention Studies UnitColeraine, United KingdomTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
University of Ulster
Trial code
NCT06425796
Record updated
1 July 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Participants who take steroids or anti-inflammatory treatments or drugs that affect gut absorption (proton-pump inhibitors); Participants with history of haematological, renal, liver, autoimmune disorders, malabsorptive syndromes; Participants with history of bariatric surgery; 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); Planned home births; Participants currently involved in another research study; Multiple pregnancy; Participants who do not speak English.

ClinicalTrials.gov NCT06425796