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Adiposity and Iron Requirements in Pregnancy

RecruitingNAAges 18 Years - anyFemaleUniversity of Ulster
NCT06425796 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria:- Pregnant women * Age โ‰ฅ 18 years * BMI โ‰ฅ18.5 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 ฮผg/L * High risk of iron overload (Hb \>150 g/L, transferrin saturation \>45% or SF\> 150 ฮผg/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
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What it tests

  • Adiposity and Iron Requirements in Pregnancy (ADIPREG)
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Where

3 sites
Causeway Hospital
Coleraine, United Kingdom
Causeway Hospital
Coleraine, United Kingdom
Ulster University,Human Intervention Studies Unit,
Coleraine, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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