Active not recruitingNAINTERVENTIONAL

Optimal Nutrition for Prevention of Hypertension in Pregnancy

This study aims to understand if a specific gene, called MTHFR 677C→T, plays a role in how a woman's blood pressure behaves during pregnancy. Researchers also want to see if taking extra B vitamins, specifically riboflavin alone or with folate (5-MTHF), can help pregnant women with a particular version of this gene to keep their blood pressure healthy. The study will also track the blood pressure of their babies after birth to see if the vitamins taken by the mother have any long-term effects. This research could lead to new, non-drug ways to help manage blood pressure during pregnancy.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Ulster

Enrolment target

2,250

Start

01 Mar 2017

Estimated completion

31 Dec 2025

Blood Pressure Pregnancy

What is this study about?

This study is looking into a common question: can certain nutrients help keep blood pressure healthy during pregnancy? Specifically, researchers are focusing on a particular gene variation that some women have. This gene is called MTHFR 677C→T, and if you have certain versions of it, it might affect how your body uses B vitamins like folate and riboflavin.

The main goal is to see if women who have a specific version of this MTHFR gene (called the TT genotype) have different blood pressure patterns during pregnancy. Then, they want to test if giving these women a vitamin B called riboflavin, either by itself or combined with another B vitamin called 5-methyltetrahydrofolate (a type of folate), can help manage their blood pressure without using medicines. This could offer a simple, natural approach to supporting healthy blood pressure for these women.

Beyond the mother's health, the study will also look at the babies. If a mother takes these supplements during pregnancy, researchers want to know if it affects her baby's blood pressure in the first few years of life. By understanding the link between genes, vitamins, and blood pressure in both mothers and babies, this research hopes to find better ways to support healthy pregnancies for many women.

Key takeaways

Looks at how a specific gene (MTHFR) might affect blood pressure in pregnancy.
Investigates if B vitamins (riboflavin and folate) can help manage blood pressure for some pregnant women.
Studies the long-term effect of these vitamins on the baby's blood pressure.
Participation involves taking supplements (or a dummy pill) and regular health checks.
Aims to find non-drug ways to support healthy pregnancies.
Participation involves several visits and follow-ups up to 3 years after birth.

Who may be eligible?

To join this study, you need to be pregnant with one baby and be in your first three months of pregnancy. The study wants to check if you have a specific gene variation that helps your body use B vitamins.

However, you cannot take part if you have a high-risk pregnancy, or if you or someone in your close family has had a pregnancy affected by a condition called a neural tube defect. You also can't participate if you're taking any medications that might interfere with how your body uses B vitamins.

Quick self-check

Are you currently pregnant with one baby?
Are you in your first 12 weeks (first trimester) of pregnancy?
Do you have a non-high-risk pregnancy?
Are you not taking medications that affect B vitamin use?
Do you or your close family not have a history of neural tube defects?
Are you happy to provide a cheek swab for genetic testing?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first be asked to sign a consent form and fill out a health questionnaire. You'll also provide a simple cheek swab to check for a specific gene. If you have the gene version the study is interested in, or are in a comparison group, you might be asked to continue.

Starting around 16 weeks of pregnancy, you'll be given either riboflavin, riboflavin combined with 5-methyltetrahydrofolate (a type of folate), or a dummy pill (placebo) to take every day until the end of your pregnancy. Neither you nor the study team will know which one you are taking. You'll have blood samples taken and your blood pressure and measurements checked at 16 weeks and again at 36 weeks. You'll also fill out a questionnaire about your health, lifestyle, and what you eat for four days.

After your baby is born, samples from the umbilical cord and placenta will be collected, and your baby's measurements will be taken. Finally, both your and your baby's blood pressure will be measured when your baby is around 2-4 months old and again at 3 years old. A separate group of women with a different gene type will also be monitored without supplements to see normal pregnancy changes. This study aims to understand normal pregnancy changes and the effect of the supplements, if you are offered them.

Potential risks and benefits

Participating in this study might offer you the benefit of close monitoring of your health during pregnancy and could contribute to valuable research that helps future pregnant women. The supplements used (riboflavin and 5-methyltetrahydrofolate) are generally considered safe B vitamins, but like all substances, there's always a small chance of unexpected side effects, though none are specifically anticipated beyond what's expected for typical vitamin use. You might experience some minor discomfort from blood tests. You are free to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (3)

Letterkenny University Hospital
Letterkenny, Ireland
Northern Health and Social Care Trust
Coleraine, United Kingdom
Western Health and Social Care Trust
Londonderry, United Kingdom

Common questions

What is the MTHFR gene?

It's a gene that helps your body use B vitamins. Some people have a slightly different version of this gene that the study is interested in.

What are riboflavin and 5-methyltetrahydrofolate?

These are types of B vitamins, also known as Vitamin B2 and a natural form of folate (Vitamin B9), respectively. They are important for many body functions.

Will I know if I'm taking the vitamins or a dummy pill?

No, this is a 'double-blind' study, meaning neither you nor the research team will know who is getting the active vitamins and who is getting the dummy pill until after the study ends.

Why is my baby's blood pressure being measured?

The study wants to see if the vitamins taken by the mother during pregnancy have any effect on the baby's blood pressure later in childhood.

How often will I need to visit the clinic?

You'll have a screening visit, then follow-up visits around 16 weeks and 36 weeks of pregnancy. There will also be follow-up measurements for you and your baby at 2-4 months and 3 years after birth.