Exploring how body fat affects iron supplement response during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of maternal adiposity on the effectiveness of daily iron supplementation during pregnancy. A total of 312 pregnant women will be randomly assigned to receive either 25 or 50 mg of iron supplements from 12 weeks of pregnancy until delivery. Blood samples will be collected at various stages of pregnancy to assess iron levels and other health markers. The study aims to understand how body fat influences iron absorption and overall maternal and neonatal health outcomes.

Why it matters

Who can join: the full rules

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's running

• Causeway Hospital
  Coleraine, Co Londonderry, United Kingdom Recruiting
• Causeway Hospital
  Coleraine, Co. Londonderry, United Kingdom Recruiting
• Ulster University,Human Intervention Studies Unit,
  Coleraine, Co. Londonderry, United Kingdom Recruiting

Study contacts

• Study coordinator: Mary T McCann, PhD
• Email: mt.mccann@ulster.ac.uk
• Phone: +4402870123969

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.