Exploring how body fat affects iron supplement response during pregnancy
Impact of Maternal Adiposity on Maternal Iron Status and Requirements: a Randomised Intervention Study
This study is testing how body fat affects how well iron supplements work for pregnant women to see if it impacts their health and their baby's health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Ulster Academic / other |
| Locations | 3 sites (Coleraine, Co Londonderry and 2 other locations) |
| Trial ID | NCT06425796 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 years and older with a BMI of 18.5 kg/m2 or higher and without current pregnancy complications.
Not a fit: Patients with existing anemia, high risk of iron overload, or those with certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved iron supplementation strategies for pregnant women, enhancing maternal and neonatal health.
How similar studies have performed: Other studies have shown varying success in understanding the relationship between body fat and iron supplementation, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Coleraine, Co Londonderry and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.