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Vitamin B2 and folate may prevent pregnancy hypertension in women with gene variant

NCT ID NCT04723836

Prevention Sponsor: University of Ulster Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether taking riboflavin (vitamin B2) and a form of folate can prevent high blood pressure in pregnant women who have a specific gene variant (MTHFR TT). About 2250 women in their first trimester are being recruited. Those with the gene variant will receive the vitamins or a placebo from week 16 until delivery. The goal is to see if this personalized nutrition approach can keep blood pressure healthy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Riboflavin (Vitamin B2) and 5-methyltetrahydrofolate (a form of folate)
What this could lead to
If it works, this could offer a simple, non-drug way to prevent high blood pressure during pregnancy for women with a specific gene variant.
What could go wrong
This is a mid-stage trial, so results are not yet proven. The approach only applies to women with a specific gene variant, and the effect on blood pressure may be small.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2017

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • Women with a singleton pregnancy who are in their first trimester of pregnancy Exclusion Criteria: * Patients who have a high risk pregnancy, a previous pregnancy with a neural tube defect (NTD) or are the first degree relative of a woman who had a pregnancy affected by NTD or are themselves a sufferer of an NTD * Women who are taking medication known to interfere with B-vitamin metabolism

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Conditions

The condition(s) this trial relates to.

hypertensive disorder hypertension, pregnancy-induced prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood pressure Pregnancy

Contacts and locations

Locations

  • Letterkenny University Hospital

    Letterkenny, Ireland

  • Northern Health and Social Care Trust

    Coleraine, N.Ireland, BT52 1HS, United Kingdom

  • Western Health and Social Care Trust

    Londonderry, N.Ireland, BT47 6SB, United Kingdom

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