Study of How Body Fat Affects Iron Needs During Pregnancy Using Daily Iron Supplements

What this Trial Is About

Researchers are investigating how body fat affects the response to daily iron supplements of either 25 mg or 50 mg during pregnancy. The study focuses on pregnant women aged 18 years or older with a single pregnancy and without current complications. This double-blind randomized controlled trial will include 312 participants recruited from antenatal clinics to explore how maternal adiposity influences iron status and requirements. Participants will be randomly assigned to one of two groups receiving either 25 mg or 50 mg of elemental iron daily, combined with a multivitamin supplement. The supplements are taken together each morning from 12 weeks of pregnancy until delivery. Blood and umbilical cord samples will be collected at various pregnancy stages, and an additional postpartum sample at 8 weeks is optional. The study also involves questionnaires on health, lifestyle, mental health, and gastrointestinal symptoms, with compliance and adverse effects monitored by scheduled phone calls. Throughout the study, participants will have blood samples and body measurements taken at 12, 28, and 36 weeks of gestation, with umbilical cord blood collected at birth. Questionnaires and 4-day diaries will track dietary intake and lifestyle. Researchers will assess iron and inflammation markers, mental health scores, and genetic factors related to iron metabolism. Participants may be withdrawn if diagnosed with anemia, prescribed iron treatment, or if adverse outcomes occur. Electronic forms will be used for data collection, and the total participation spans from early pregnancy until delivery, with an optional postpartum follow-up.

Adiposity and Iron Requirements in Pregnancy