Adiposity and iron requirements in pregnancy V1

• Research type

  Research Study

• Full title

  Impact of maternal adiposity on maternal iron status and requirements: a randomised intervention study

• IRAS ID

  334363

• Contact name

  Mary McCann

• Contact email

  mt.mccann@ulster.ac.uk

• Sponsor organisation

  University of Ulster

• Duration of Study in the UK

  1 years, 9 months, 1 days

• Research summary

  Women of reproductive age and pregnant women need more iron for fetal growth, replacing menstrual and childbirth losses. Severe iron deficiency leads to anaemia with symptoms like fatigue, headaches, and risks for pregnancy complications. Babies born to mothers with anaemia face higher neonatal risks. Despite the higher demand for iron during pregnancy and the high prevalence of iron deficiency and anaemia in pregnant women, routine supplementation with iron is not part of the current recommendations. It may also be the case that women with a higher body weight need higher doses of supplemental iron to meet increased nutritional demands. The UK Guidelines do not currently recommend routine screening for this deficiency, recommending only screening for its most severe form, anaemia.

  With this study we intend to evaluate which of two doses, 25 mg versus 50 mg of iron, are the most adequate to optimise iron status in women with normal weight, overweight and obesity. We propose a randomised supplementation study where pregnant women (n 310) from Causeway Hospital will be invited to take part.
  Inclusion criteria:
  - Pregnant women
  - Age ≥ 18 years
  - BMI ≥18.5 kg/m2
  - Without current pregnancy complications
  - At least 12 weeks' gestation
  - 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. Participants will be randomised to receive either 25 mg plus a multivitamin or 50 mg iron plus multivitamin. Blood samples will be taken at 12, 28, 36 weeks' gestation. An umbilical cord blood sample will be collected at birth. Body composition measurements will be recorded at each timepoint. The intervention will begin at 12 weeks gestation until the delivery of the baby. Health and lifestyle information as well as assessments on mental health will also be recorded.

• REC name

  HSC REC B

• REC reference

  24/NI/0027

• Date of REC Opinion

  29 Mar 2024

• REC opinion

  Further Information Favourable Opinion