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Adiposity and Iron Requirements in Pregnancy
Sponsor: University of Ulster
Summary
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.
Official title: Impact of Maternal Adiposity on Maternal Iron Status and Requirements: a Randomised Intervention Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2024-05-20
Completion Date
2027-03-19
Last Updated
2026-07-01
Healthy Volunteers
Yes
Conditions
Interventions
Adiposity and Iron Requirements in Pregnancy (ADIPREG)
Iron 25 arm will receive: two iron supplements containing 12.5 mg of elemental iron + 1 multivitamin supplement (they will receive a total of 3 supplements per day). Iron 50 arm will receive: two 25 mg elemental iron supplements + 1 multivitamin supplement (they will receive a total of 3 supplements per day). The multivitamin supplement will contain folic acid, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, vitamin C and vitamin D. In summary, each participant will receive 3 supplements per day and instructed to take the 3 supplements together, in the morning, with breakfast. Supplements will be given to the participants when they attend for their clinic appointment. The intervention will begin at 12 gestational weeks and continue until the baby is delivered.
Locations (3)
Causeway Hospital
Coleraine, Co Londonderry, United Kingdom
Causeway Hospital
Coleraine, Co. Londonderry, United Kingdom
Ulster University,Human Intervention Studies Unit,
Coleraine, Co. Londonderry, United Kingdom