Infant Vitamin K StatusNCT07620236
The OK Daily Study
A study testing Combined MK-7 + vitamin D3 drops, Vitamin D3 Drops and MK-7 capsules in people with Infant Vitamin K Status and Vitamin K Deficiency Bleeding, run by Norfolk and Norwich University Hospitals NHS Foundation Trust.
Trial summary
The OK Daily Study is a multi-centred, part-randomised, part blinded, four cohort study. We are exploring daily dietary supplementation with vitamin K2, specifically menaquinone-7 (MK-7), given to breastfed infants or breastfeeding mothers to see whether this improves the incidence of biochemical vitamin K deficiency… Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Vitamin K Status, Vitamin K Deficiency Bleeding
- What is being tested?
- Combined MK-7 + vitamin D3 drops, Vitamin D3 Drops and MK-7 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Carianne Dr Lewis contact
About this study
Official title: Oral Vitamin K2 (Menaquinone-7; MK-7) Supplementation and Effect on Vitamin K Status of Breastfed Term Infants in Early Infancy; a Four-cohort Prospective, Part-randomised, Part-blinded Study.
The OK Daily Study is a multi-centred, part-randomised, part blinded, four cohort study. We are exploring daily dietary supplementation with vitamin K2, specifically menaquinone-7 (MK-7), given to breastfed infants or breastfeeding mothers to see whether this improves the incidence of biochemical vitamin K deficiency in the infants at 2 months postnatal age.
The overall aims are:
Read more
- To compare infant MK-7 supplementation with placebo
- To compare maternal MK-7 supplementation with placebo
- To compare infant MK-7 supplementation and maternal MK-7 supplementation
- To compare infant MK-7 supplementation with vitamin K1 supplementation via infant formula milk.
Once recruited, mother and infant pairs will be grouped initially based on the families' feeding choice. Breastfed infants will then be randomised 2:1 to the infant supplementation or maternal supplementation group. Within the infant supplementation group, infants will either receive MK-7 with vitamin D or a placebo containing vitamin D.
Follow up will occur at 2 months postnatal age (range 2-3 months postnatal age), where bloods and breastmilk samples will be collected to assess the infant and maternal vitamin K status.
Read the detailed description
The OK Daily Study is a multi-centre study taking place in the Norfolk and Norwich University Hospital, Norwich, UK, and Ashford and St Peters' Hospital, Chertsey, UK.
Infants born at ≥37 weeks' gestation will be recruited in the participating site if they meet eligibility criteria and are born within the recruitment window. Recruitment will take place before the mother and infant are discharged from the hospital following birth.
The two main arms of this study are breastfeeding and formula feeding. Mother and infant pairs will initially be allocated based on the family's feeding preferences.
Infants in the breastfeeding arm will be randomised into group 1 or group 2 in a 2:1 ratio. Group 1 allocation will be blinded; group 2 allocation will be open label.
- Group 1 - infant supplementation group. Infants will receive either 45 micrograms/day of MK-7 with 10 micrograms/day vitamin D3 or a placebo consisting of 10 micrograms/day vitamin D3
- Group 2 - maternal supplementation group. Mothers in this group will receive 2 mg/day MK-7. All breastfeeding infants in this group will receive 10 micrograms/day of vitamin D3.
Formula fed infants will be in group 3 and will not require any additional supplementation as part of this study. This is because infant formula is already supplemented with adequate amounts of vitamin K1 and vitamin D.
All supplements will be started within 7 days of birth. Vitamin D drops are included for breastfed infants as per national UK guidelines.
Follow up will be as follows:
- 1 month postnatal visit (range 1-1.5 months) - phone call.
- Confirmation of eligibility to continue, assessment of compliance with the intervention, and to schedule the in person follow up visit
- 2 months postnatal (range 2-3 months) - in person visit.
- All babies will have a single blood sample taken.
- Mothers who are in group 2 (mothers who have had MK-7 supplementation) and a selection of mothers from group 1 (breastfeeding mothers who are not supplemented with MK-7) will have a single blood sample taken and will be asked to provide a single breastmilk sample
- Mothers will be asked about their opinions on practising the supplementation.
Blood samples will be analysed for vitamin K status, including Proteins Induced by Vitamin K Absence/antagonism of prothrombin (PIVKA-II) and of osteocalcin (undercarboxylated osteocalcin), dephosphorylated-undercarboxylated matrix gla-protein (dp-ucMGP) and serum vitamin K concentrations (including of vitamin K1 and MK-7). Breastmilk samples will be analysed for vitamin K concentrations (including vitamin K1 and MK-7)
Once this in person follow up visit has been completed, the mother and baby pair will have completed the study.
- Being tested
- Combined MK-7 + vitamin D3 drops, Vitamin D3 Drops, MK-7 capsules
- Keywords
- Oral vitamin K, vitamin K1 vs K2, menaquinone-7 (MK-7), vitamin K status, PIVKA-II, undercarboxylated/carboxylated osteocalcin ratio, neonate, infant, breastfeeding
- Medical subject headings
- Vitamin K Deficiency Bleeding, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined MK-7 + vitamin D3 dropsOther
Also called Vitamin K2 supplemented infant group
6 drops/day providing 45 micrograms/day MK-7 plus 10 micrograms/day of vitamin D3
Vitamin D3 DropsOther
Also called Vitamin K2 unsupplemented group
6 drops/day providing 10 micrograms/day vitamin D3 and no supplementary MK-7.
MK-7 capsulesOther
1 mg capsules of menaquinone-7, with a daily dose of 2 mg (i.e. 2 capsules per day)
| Study group | Role | What they receive |
|---|---|---|
| Mother and infant pairs who are breastfeeding. | Other | Group 1 = infant supplementation group. Infants in this group will be randomised to receive either 6 drops a day containing 45 micrograms/day of MK-7 plus 10 micrograms/day vitamin D3 OR 10 micrograms/day vitamin D3 only (the active placebo, containing no vitamin K)
Group 2 = maternal supplementation group. Mothers in this group will be given 2 mg/day MK-7 capsules. Infants in this group will receive 10 micrograms/day vitamin D3. Receives: Other: Combined MK-7 + vitamin D3 drops; Other: Vitamin D3 Drops; Other: MK-7 capsules |
| Formula Feeding Infants | Active comparator | Infants who are exclusively formula feeding. These infants will receive the recommended daily amount of vitamin K through their formula milk intake and so will not receive any additional vitamin K supplementation. Receives: Other: Vitamin D3 Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the unsupplemented and supplemented infants.
PIVKA-II = protein induced by vitamin K antagonism/absence; clotting protein II.
Measured via serum blood sample in arbitrary units/mL. For the primary outcome, this is the comparison between the supplemented and unsupplemented infants.
Measured: 2 months postnatal age (range 2-3 months).
Secondary outcomes (8)
Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the various study groups.
PIVKA-II = protein induced by vitamin K antagonism/absence; clotting protein II.
Measured via serum blood sample in arbitrary units/mL. For secondary outcome, this is comparison between remaining groups, other than those assessed in the primary outcome measure.
Measured: 2 months postnatal age (range 2-3 months).
Comparison of serum levels of osteocalcin (undercarboxylated and carboxylated) between the study groups.
Both undercarboxylated and carboxylated levels of osteocalcin will be measured in nanograms/mL.
Measured: 2 months postnatal age (range 2-3 months).
Comparison of the percentage of undercarboxylated osteocalcin as a proportion of total osteocalcin (%GluOC) between the study groups.
Total osteocalcin calculated by the sum of the undercarboxylated and carboxylated osteocalcin values.
Measured: 2 months postnatal age (range 2-3 months).
Comparison of serum levels of dephosphorylated undercarboxylated matrix Gla Protein in included participants between the study groups.
Measured in picomol/mL
Measured: 2 months postnatal age (range 2-3 months).
Comparison of levels of serum K vitamers (including, but no limited to, vitamin K1 and menaquinone-7) between the study groups.
Serum K vitamers will be reported in micrograms/mL.
Measured: 2 months postnatal age (range 2-3 months).
Comparison of the levels of breastmilk K vitamers (including, but not limited to, vitamin K1 and menaquinone-7) between unsupplemented and supplemented mothers.
Serum K vitamers will be reported in nanograms/mL
Measured: 2 months postnatal age (range 2-3 months).
Investigation of percentage compliance to study supplementation.
Amount of remaining supplement will be assessed at follow up. This will then be used to calculate percentage compliance by comparing it to the expected volumes.
Measured: 2 months postnatal age (range 2-3 months).
Investigation regarding families' opinions about infant and maternal vitamin supplementation.
Measured via verbal questioning at follow up.
Measured: 2 months postnatal age (range 2-3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infant Vitamin K StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Guy's and St Thomas' NHS Foundation Trust, Ashford and St. Peter's Hospitals NHS Trust, University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Paul Clarke, Professor, Principal investigator, Norfolk and Norwich University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620236
- Sponsor's protocol ID
- 150-12-25
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schurgers LJ, Teunissen KJ, Hamulyak K, Knapen MH, Vik H, Vermeer C. Vitamin K-containing dietary supplements: comparison of synthetic vitamin K1 and natto-derived menaquinone-7. Blood. 2007 Apr 15;109(8):3279-83. doi: 10.1182/blood-2006-08-040709. Epub 2006 Dec 7.
PubMed 17158229Perrone S, De Bernardo G, Lembo C, Dell'Orto V, Giordano M, Beretta V, Petrolini C, Gambini L, Toni AL, Parigi G, Fontanarosa I, Natale MP, D'Amato G, Sordino D, Buonocore G. Vitamin K insufficiency and the prophylaxis strategy in term healthy infants: A multicentre study. Eur J Clin Invest. 2024 Apr;54(4):e14141. doi: 10.1111/eci.14141. Epub 2023 Dec 9.
PubMed 38071415Clarke P, Shearer MJ, Card DJ, Nichols A, Ponnusamy V, Mahaveer A, Voong K, Dockery K, Holland N, Mulla S, Hall LJ, Maassen C, Lux P, Schurgers LJ, Harrington DJ. Exclusively breastmilk-fed preterm infants are at high risk of developing subclinical vitamin K deficiency despite intramuscular prophylaxis at birth. J Thromb Haemost. 2022 Dec;20(12):2773-2785. doi: 10.1111/jth.15874. Epub 2022 Oct 3.
PubMed 36087073Clarke P, Mitchell SJ, Shearer MJ. Total and Differential Phylloquinone (Vitamin K1) Intakes of Preterm Infants from All Sources during the Neonatal Period. Nutrients. 2015 Sep 25;7(10):8308-20. doi: 10.3390/nu7105393.
PubMed 26426042Clarke P, Embleton ND, Fewtrell M, Harrington DJ, Kelly AM, Moris N, Patto A, Ponnusamy V, Vasu V, Shearer MJ. Vitamin K: missed at peril-the case for extra supplementation to prevent deficiency in breastfed preterm infants. Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):679-680. doi: 10.1136/archdischild-2023-326737. No abstract available.
PubMed 38429074
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Vitamin K2 (Menaquinone-7; MK-7) Supplementation and Effect on Vitamin K Status of Breastfed Term Infants in Early Infancy; a Four-cohort Prospective, Part-randomised, Part-blinded Study.
- ClinicalTrials.gov ID
- NCT07620236
- Acronym / sponsor ID
- 150-12-25
- Keywords
- Oral vitamin K, vitamin K1 vs K2, menaquinone-7 (MK-7), vitamin K status, PIVKA-II, undercarboxylated/carboxylated osteocalcin ratio, neonate, infant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Maastricht University, Guy's and St Thomas' NHS Foundation Trust, Ashford and St. Peter's Hospitals NHS Trust, University of East Anglia
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The OK Daily Study is a multi-centred, part-randomised, part blinded, four cohort study. We are exploring daily dietary supplementation with vitamin K2, specifically menaquinone-7 (MK-7), given to breastfed infants or breastfeeding mothers to see whether this improves the incidence of biochemical vitamin K deficiency in the infants at 2 months postnatal age.
The overall aims are:
- To compare infant MK-7 supplementation with placebo
- To compare maternal MK-7 supplementation with placebo
- To compare infant MK-7 supplementation and maternal MK-7 supplementation
- To compare infant MK-7 supplementation with vitamin K1 supplementation via infant formula milk.
Once recruited, mother and infant pairs will be grouped initially based on the families' feeding choice. Breastfed infants will then be randomised 2:1 to the infant supplementation or maternal supplementation group. Within the infant supplementation group, infants will either receive MK-7 with vitamin D or a placebo containing vitamin D.
Follow up will occur at 2 months postnatal age (range 2-3 months postnatal age), where bloods and breastmilk samples will be collected to assess the infant and maternal vitamin K status.
Detailed description
The OK Daily Study is a multi-centre study taking place in the Norfolk and Norwich University Hospital, Norwich, UK, and Ashford and St Peters' Hospital, Chertsey, UK.
Infants born at ≥37 weeks' gestation will be recruited in the participating site if they meet eligibility criteria and are born within the recruitment window. Recruitment will take place before the mother and infant are discharged from the hospital following birth.
The two main arms of this study are breastfeeding and formula feeding. Mother and infant pairs will initially be allocated based on the family's feeding preferences.
Infants in the breastfeeding arm will be randomised into group 1 or group 2 in a 2:1 ratio. Group 1 allocation will be blinded; group 2 allocation will be open label.
- Group 1 - infant supplementation group. Infants will receive either 45 micrograms/day of MK-7 with 10 micrograms/day vitamin D3 or a placebo consisting of 10 micrograms/day vitamin D3
- Group 2 - maternal supplementation group. Mothers in this group will receive 2 mg/day MK-7. All breastfeeding infants in this group will receive 10 micrograms/day of vitamin D3.
Formula fed infants will be in group 3 and will not require any additional supplementation as part of this study. This is because infant formula is already supplemented with adequate amounts of vitamin K1 and vitamin D.
All supplements will be started within 7 days of birth. Vitamin D drops are included for breastfed infants as per national UK guidelines.
Follow up will be as follows:
- 1 month postnatal visit (range 1-1.5 months) - phone call.
- Confirmation of eligibility to continue, assessment of compliance with the intervention, and to schedule the in person follow up visit
- 2 months postnatal (range 2-3 months) - in person visit.
- All babies will have a single blood sample taken.
- Mothers who are in group 2 (mothers who have had MK-7 supplementation) and a selection of mothers from group 1 (breastfeeding mothers who are not supplemented with MK-7) will have a single blood sample taken and will be asked to provide a single breastmilk sample
- Mothers will be asked about their opinions on practising the supplementation.
Blood samples will be analysed for vitamin K status, including Proteins Induced by Vitamin K Absence/antagonism of prothrombin (PIVKA-II) and of osteocalcin (undercarboxylated osteocalcin), dephosphorylated-undercarboxylated matrix gla-protein (dp-ucMGP) and serum vitamin K concentrations (including of vitamin K1 and MK-7). Breastmilk samples will be analysed for vitamin K concentrations (including vitamin K1 and MK-7)
Once this in person follow up visit has been completed, the mother and baby pair will have completed the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mother and infant pairs who are breastfeeding. | Other | Other: Combined MK-7 + vitamin D3 drops, Other: Vitamin D3 Drops, Other: MK-7 capsulesGroup 1 = infant supplementation group. Infants in this group will be randomised to receive either 6 drops a day containing 45 micrograms/day of MK-7 plus 10 micrograms/day vitamin D3 OR 10 micrograms/day vitamin D3 only (the active placebo, containing no vitamin K) Group 2 = maternal supplementation group. Mothers in this group will be given 2 mg/day MK-7 capsules. Infants in this group will receive 10 micrograms/day vitamin D3. |
| Formula Feeding Infants | Active comparator | Other: Vitamin D3 DropsInfants who are exclusively formula feeding. These infants will receive the recommended daily amount of vitamin K through their formula milk intake and so will not receive any additional vitamin K supplementation. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined MK-7 + vitamin D3 dropsAlso: Vitamin K2 supplemented infant group6 drops/day providing 45 micrograms/day MK-7 plus 10 micrograms/day of vitamin D3 | Other | Mother and infant pairs who are breastfeeding. |
| Vitamin D3 DropsAlso: Vitamin K2 unsupplemented group6 drops/day providing 10 micrograms/day vitamin D3 and no supplementary MK-7. | Other | Formula Feeding Infants, Mother and infant pairs who are breastfeeding. |
| MK-7 capsules1 mg capsules of menaquinone-7, with a daily dose of 2 mg (i.e. 2 capsules per day) | Other | Mother and infant pairs who are breastfeeding. |
Primary outcome
Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the unsupplemented and supplemented infants.
Time frame: 2 months postnatal age (range 2-3 months).
PIVKA-II = protein induced by vitamin K antagonism/absence; clotting protein II. Measured via serum blood sample in arbitrary units/mL. For the primary outcome, this is the comparison between the supplemented and unsupplemented infants.
8 secondary outcomes
Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the various study groups.
Time frame: 2 months postnatal age (range 2-3 months).
Comparison of serum levels of osteocalcin (undercarboxylated and carboxylated) between the study groups.
Time frame: 2 months postnatal age (range 2-3 months).
Comparison of the percentage of undercarboxylated osteocalcin as a proportion of total osteocalcin (%GluOC) between the study groups.
Time frame: 2 months postnatal age (range 2-3 months).
Comparison of serum levels of dephosphorylated undercarboxylated matrix Gla Protein in included participants between the study groups.
Time frame: 2 months postnatal age (range 2-3 months).
Comparison of levels of serum K vitamers (including, but no limited to, vitamin K1 and menaquinone-7) between the study groups.
Time frame: 2 months postnatal age (range 2-3 months).
Comparison of the levels of breastmilk K vitamers (including, but not limited to, vitamin K1 and menaquinone-7) between unsupplemented and supplemented mothers.
Time frame: 2 months postnatal age (range 2-3 months).
Investigation of percentage compliance to study supplementation.
Time frame: 2 months postnatal age (range 2-3 months).
Investigation regarding families' opinions about infant and maternal vitamin supplementation.
Time frame: 2 months postnatal age (range 2-3 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 17158229Schurgers LJ, Teunissen KJ, Hamulyak K, Knapen MH, Vik H, Vermeer C. Vitamin K-containing dietary supplements: comparison of synthetic vitamin K1 and natto-derived menaquinone-7. Blood. 2007 Apr 15;109(8):3279-83. doi: 10.1182/blood-2006-08-040709. Epub 2006 Dec 7.
- Background: PubMed 38071415Perrone S, De Bernardo G, Lembo C, Dell'Orto V, Giordano M, Beretta V, Petrolini C, Gambini L, Toni AL, Parigi G, Fontanarosa I, Natale MP, D'Amato G, Sordino D, Buonocore G. Vitamin K insufficiency and the prophylaxis strategy in term healthy infants: A multicentre study. Eur J Clin Invest. 2024 Apr;54(4):e14141. doi: 10.1111/eci.14141. Epub 2023 Dec 9.
- Background: PubMed 36087073Clarke P, Shearer MJ, Card DJ, Nichols A, Ponnusamy V, Mahaveer A, Voong K, Dockery K, Holland N, Mulla S, Hall LJ, Maassen C, Lux P, Schurgers LJ, Harrington DJ. Exclusively breastmilk-fed preterm infants are at high risk of developing subclinical vitamin K deficiency despite intramuscular prophylaxis at birth. J Thromb Haemost. 2022 Dec;20(12):2773-2785. doi: 10.1111/jth.15874. Epub 2022 Oct 3.
- Background: PubMed 26426042Clarke P, Mitchell SJ, Shearer MJ. Total and Differential Phylloquinone (Vitamin K1) Intakes of Preterm Infants from All Sources during the Neonatal Period. Nutrients. 2015 Sep 25;7(10):8308-20. doi: 10.3390/nu7105393.
- Background: PubMed 38429074Clarke P, Embleton ND, Fewtrell M, Harrington DJ, Kelly AM, Moris N, Patto A, Ponnusamy V, Vasu V, Shearer MJ. Vitamin K: missed at peril-the case for extra supplementation to prevent deficiency in breastfed preterm infants. Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):679-680. doi: 10.1136/archdischild-2023-326737. No abstract available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carianne Dr Lewis contact
Paul Clarke, Professor principal investigator
Norfolk and Norwich University Hospitals NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Combined MK-7 + vitamin D3 drops, Vitamin D3 Drops and MK-7 capsules in people with Infant Vitamin K Status and Vitamin K Deficiency Bleeding, run by Norfolk and Norwich University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Professor Clarke (01603 286286, PAUL.CLARKE@nnuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the proportion of participants who have a PIVKA-II >0.05 AU/mL in the unsupplemented and supplemented infants. (time frame: 2 months postnatal age (range 2-3 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07620236, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.