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Vitamin K2 drops could shield breastfed infants from bleeding risk

NCT ID NCT07620236

Prevention Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This study tests whether giving vitamin K2 (MK-7) supplements to breastfed infants or their breastfeeding mothers can prevent vitamin K deficiency at 2 months of age. About 134 healthy, full-term babies who received standard vitamin K shots at birth will be enrolled. Some infants will get MK-7 drops, others a placebo, and some mothers will take MK-7 capsules. The goal is to see if extra vitamin K2 improves blood markers of vitamin K status and reduces the risk of rare but serious bleeding.

What this could mean

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

Active substance
Vitamin K2 (menaquinone-7; MK-7) drops or capsules, with or without vitamin D3
What this could lead to
If it works, this could point toward a simple daily supplement to prevent vitamin K deficiency and related bleeding in breastfed babies.
What could go wrong
This is an early, small study (134 infants) that has not yet started recruiting. It may not show a clear benefit, and results may not apply to all infants.

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 134 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

Up to 7 days

Sex

Anyone

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: * Infants, and mothers of infants, born ≥37 weeks gestational age * Standard dose of intramuscular (IM) vitamin K prophylaxis given to the neonate following birth * For breastfeeding mothers: the mother intends to exclusively/predominantly breastfeed their baby for at least 2 months Exclusion Criteria: * Inability or refusal to provide informed consent * Inability to adhere to or comply with study procedures * Babies who meet the inclusion gestation but would otherwise, as part of routine neonatal care, be provided with daily vitamin K drops (i.e. NeoKay drops) at discharge * IM vitamin K prophylaxis not received at birth (parents declined vitamin K prophylaxis or parents chose for neonate to receive an oral course of vitamin K prophylaxis instead) * Evidence of conjugated hyperbilirubinaemia (these babies are at higher risk of VKDB) * Mothers, and babies born to mothers, who are taking any medication that could affect or antagonise vitamin K metabolism (i.e. warfarin, the anti-epileptic drugs phenytoin or carbamazepine, and cephalosporin, rifampicin and isoniazid antimicrobials)

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Conditions

The condition(s) this trial relates to.

Breast Feeding hemorrhagic disease of newborn vitamin K deficiency hemorrhagic disease prevention target

As listed by the trial registrant

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

Infant vitamin K status Vitamin K deficiency bleeding

How to take part

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  1. The official record

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    Open the record ↗

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