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RecruitingNAINTERVENTIONAL

Adiposity and Iron Requirements in Pregnancy

This study, called ADIPREG, is looking at how a pregnant woman's body fat might change how well iron supplements work. We want to find out if taking 25mg or 50mg of iron every day during pregnancy makes a difference, especially for women with different body weights. We'll be working with 312 pregnant women from antenatal clinics in the Northern Trust Area. Participants will be randomly given either 25mg or 50mg of Active Iron each day, starting from 12 weeks of pregnancy until their baby is born. We'll take some blood samples, measure body changes, and ask about health and feelings to understand the best way to keep iron levels healthy during pregnancy for everyone.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Ulster
Enrolment target
312
Start
20 May 2024
Estimated completion
19 Mar 2027

What is this study about?

This research project, called ADIPREG, is all about understanding how pregnant women's bodies use iron. Specifically, we're interested in how your body fat might affect how well iron supplements work. Many pregnant women need extra iron, and we want to find the best daily dose for different women to keep them and their babies healthy.

We will be inviting 312 pregnant women to take part. If you join, you'll be randomly assigned to take either a 25mg or 50mg iron supplement daily, starting from your 12th week of pregnancy until your baby arrives. We'll be looking carefully at changes in your iron levels through blood tests, and also at other health measures like your general well-being and even your mood. The main goal is to figure out if your body fat influences how effective these different iron doses are.

By doing this study, we hope to gain valuable information that could help doctors and midwives give more personalised advice about iron supplements in the future. This could lead to better health for pregnant women and their babies by ensuring everyone gets the right amount of iron for their individual needs.

Key takeaways

  • Exploring how body fat affects iron use in pregnancy.
  • Compares 25mg versus 50mg daily iron doses.
  • Involves 312 pregnant women from 12 weeks until birth.
  • Includes blood tests, body measurements, and questionnaires.
  • Aims to improve future iron supplement advice for pregnant women.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be pregnant, at least 18 years old, and have a healthy body weight (BMI of 18.5 or higher). You should be at least 12 weeks pregnant with one baby, and not currently experiencing any major pregnancy problems like severe bleeding or diabetes.

If you're already taking multivitamins, you can still join, but we'll ask you to stop your current supplements. Unfortunately, you can't participate if you have very low or very high iron levels, or certain other health conditions like liver or kidney problems, or if you've had weight-loss surgery. You also can't be in the study if you're planning a home birth, are already in another research study, or if you don't speak English.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you pregnant?
  2. Are you 18 years old or older?
  3. Are you at least 12 weeks pregnant with one baby?
  4. Do you have a healthy body weight (BMI 18.5 or more)?
  5. Do you speak and understand English?
  6. Are you NOT planning a home birth?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either a 25mg or 50mg iron supplement to take once a day from around 12 weeks of pregnancy until your baby is born. You won't know which dose you're receiving, and neither will the study team.

You'll have a few extra appointments during your pregnancy at 12, 28, and 36 weeks. At these visits, we'll take blood samples to check your iron levels and other markers, measure your body, and ask you to fill in some questionnaires about your health, how you're feeling, your diet, and if you've been taking your iron supplements regularly. When your baby is born, we'll also collect a small sample of blood from the umbilical cord. The total time you'd be involved in the study would be from around 12 weeks of pregnancy until your delivery.

Potential risks and benefits

Taking part could offer benefits by helping us understand how best to support pregnant women's iron needs, which might indirectly improve future care for many. While generally safe, some people can experience mild side effects from iron supplements, like an upset stomach or constipation. There are no known direct risks to you or your baby from participating in this study beyond the normal risks of pregnancy and routine blood tests. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual healthcare.

Locations (3)

  • Causeway Hospital
    Verified postcode
    Coleraine, United Kingdom· Recruiting
  • Causeway Hospital
    Verified postcode
    Coleraine, United Kingdom· Recruiting
  • Ulster University,Human Intervention Studies Unit,
    Verified postcode
    Coleraine, United Kingdom· Recruiting

Common questions

What is 'Adiposity'?

Adiposity is just a medical term for body fat. In this study, we're looking at how a pregnant woman's amount of body fat might affect how their body uses iron.

Why is iron important during pregnancy?

Iron is vital for making healthy red blood cells, which carry oxygen around your body and to your baby. During pregnancy, your body needs more iron to support you and your growing baby.

Will I know if I'm getting 25mg or 50mg of iron?

No, this is a 'double-blind' study, meaning neither you nor the research team will know which dose you're receiving. This helps make sure the results are fair.

What happens to my blood samples?

Your blood samples will be tested to measure your iron levels, inflammation markers, and other aspects of your health throughout your pregnancy as part of the study.

Will this study affect my normal antenatal care?

No, joining this study will not affect your usual antenatal appointments or care. This study is in addition to your standard care.

How to find out more

Mary T McCann, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Adiposity and Iron Requirements in Pregnancy…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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