Vitamin B-12 DeficiencyB-BABIESNCT07163962
THE B-BABIES STUDY: An Observational Study of Group B Vitamins in Preterm Infants
An observational study of Vitamin B-12 Deficiency, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Infancy may be associated with a risk of micronutrient depletion due to the high demands of rapid growth. This is particularly true when preterm birth occurs, as the period before term exhibits the highest rate of bodily growth across the lifespan. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Vitamin B-12 Deficiency
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Observational
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants (born <37 weeks of gestation)
Who may be able to join
- Gestational age at birth <37 weeks.
- Admission to one of the participating units.
- Full enteral milk feeds established by suck/nasogastric tube
Who cannot join
- Known or suspected chromosomal, genetic or metabolic abnormalities.
- Major congenital malformations
- Any intercurrent condition that precludes implementation of standard feeding protocols and requires specialized formulas or changes in standard vitamin supplementation.
- Any intercurrent condition that will interfere with the interpretation of results (renal impairment and hypothyroidism can lead to elevated tHcy and MMA, for example).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Professor Martin Warren contact
United Kingdom1 site
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich
Julie Dawson, +441603 647882, Julie.dawson@nnuh.nhs.uk
Dr Isabel Iglesias-Platas, isabel.iglesias-platas@nnuh.nhs.uk
About this study
Official title: Maternal, Milk and Baby Markers of Group B Vitamin Metabolism in (Very) Preterm Infants at the Time of Discharge Home
Infancy may be associated with a risk of micronutrient depletion due to the high demands of rapid growth. This is particularly true when preterm birth occurs, as the period before term exhibits the highest rate of bodily growth across the lifespan. Folate and vitamin B12 are essential in development, and preterm infants may be particularly susceptible to deficiencies. This is the result of a combination of low stores and high requirements for fast growth and rapid red blood cell production in the context of multifactorial anaemia of prematurity. Micronutrient supply, including vitamin B12 and folate, is delivered through nutritional support, in the shape of parenteral nutrition, fortification of human milk of use of artificial formula. Most of this supplementation will be interrupted by the time the infant is getting ready for discharge home. The investigators previously reported high levels of serum folate in preterm infants at the time of discharge home and in early infancy, but there are no contemporary studies investigating the vitamin B12/folate status in this population. The investigators aim to investigate the prevalence of vitamin B12 deficiency in preterm infants at the time of discharge home.
Read the detailed description
This is an observational, cross-sectional study of infants born preterm (gestational age at birth <37 weeks) and their mothers. The investigators aim to estimate the prevalence of vitamin B12 deficiency (low vitamin B12, high homocysteine and high MMA) under current nutritional guidelines in preterm (born <37 weeks) babies at the time of discharge in preterm infants under current nutritional guidelines.
The investigators will also study whether the risk of deficiency is different in those on an exclusive breast milk diet or in specific gestational age groups (late -34-36 weeks-, moderate -32-33 weeks-, very -28-32 weeks- and extremely -<28 weeks - preterm infants). Folate status will also be analysed. Exploratory outcomes include correlations between calculated intakes and vitamin levels, blood concentrations of other vitamins and cofactors in the same metabolic pathways, content of B vitamins in preterm maternal milk and performance of potential urinary markers of vitamin B12 deficiency in preterm infants.
The trial will take place in a single tertiary-level Neonatal Intensive Care Unit (NICU) and participant families will be recruited while their infant is an inpatient. The project has received Ethical Approval and Informed Consent for mother and baby/ies will be sought before participation.
This trial focuses on the population of preterm-born (<37 weeks of gestation) infants admitted to the Neonatal Unit.
- Conditions
- Vitamin B-12 Deficiency
- Keywords
- Preterm infant, vitamin B12, Folate, Folic acid, Vitamin deficiency, Micronutrition
- Medical subject headings
- Vitamin B 12 Deficiency, Premature Birth, Avitaminosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of biochemical vitamin B12 deficiency
: Percentage of preterm infants with:
- plasma cobalamin < 148 pmol/L.
- MMA concentrations >0.26 µmol/L.
- cB12 < -0.5.
Measured: between 34 and 44 weeks postmenstrual age, at the time of hospital discharge
Secondary outcomes (1)
Prevalence of biochemical vitamin B12 deficiency in each gestational age group: late (34-36 weeks at birth), moderate (32-33 weeks at birth), very (28-32 weeks at birth) and extremely (<28 weeks at birth) preterm infants at the time of hospital discharge
- Prevalence of folate deficiency (folate <10 nmol/L)/ elevated serum folate concentrations (>45.3 nmol/L) in preterm infants pre-discharge.
- Quantification of UnMetabolized Folic Acid (UMFA) levels pre-discharge in preterm infants who receive any form of extra folic acid supplementation.
Measured: between 34 and 44 weeks postmenstrual age, at the time of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin B-12 DeficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Responsible party
- Sponsor
- Investigators
- Dr Isabel Iglesias-Platas, Principal investigator, Norfolk and Norwich University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163962
- Sponsor's protocol ID
- 2024GRANT058
- Acronym
- B-BABIES
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal, Milk and Baby Markers of Group B Vitamin Metabolism in (Very) Preterm Infants at the Time of Discharge Home
- ClinicalTrials.gov ID
- NCT07163962
- Acronym / sponsor ID
- B-BABIES / 2024GRANT058
- Conditions
- Vitamin B-12 Deficiency
- Keywords
- Preterm infant, vitamin B12, Folate, Folic acid, Vitamin deficiency, Micronutrition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Sep 2025 (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.
Infancy may be associated with a risk of micronutrient depletion due to the high demands of rapid growth. This is particularly true when preterm birth occurs, as the period before term exhibits the highest rate of bodily growth across the lifespan. Folate and vitamin B12 are essential in development, and preterm infants may be particularly susceptible to deficiencies. This is the result of a combination of low stores and high requirements for fast growth and rapid red blood cell production in the context of multifactorial anaemia of prematurity. Micronutrient supply, including vitamin B12 and folate, is delivered through nutritional support, in the shape of parenteral nutrition, fortification of human milk of use of artificial formula. Most of this supplementation will be interrupted by the time the infant is getting ready for discharge home. The investigators previously reported high levels of serum folate in preterm infants at the time of discharge home and in early infancy, but there are no contemporary studies investigating the vitamin B12/folate status in this population. The investigators aim to investigate the prevalence of vitamin B12 deficiency in preterm infants at the time of discharge home.
Detailed description
This is an observational, cross-sectional study of infants born preterm (gestational age at birth <37 weeks) and their mothers. The investigators aim to estimate the prevalence of vitamin B12 deficiency (low vitamin B12, high homocysteine and high MMA) under current nutritional guidelines in preterm (born <37 weeks) babies at the time of discharge in preterm infants under current nutritional guidelines.
The investigators will also study whether the risk of deficiency is different in those on an exclusive breast milk diet or in specific gestational age groups (late -34-36 weeks-, moderate -32-33 weeks-, very -28-32 weeks- and extremely -<28 weeks - preterm infants). Folate status will also be analysed. Exploratory outcomes include correlations between calculated intakes and vitamin levels, blood concentrations of other vitamins and cofactors in the same metabolic pathways, content of B vitamins in preterm maternal milk and performance of potential urinary markers of vitamin B12 deficiency in preterm infants.
The trial will take place in a single tertiary-level Neonatal Intensive Care Unit (NICU) and participant families will be recruited while their infant is an inpatient. The project has received Ethical Approval and Informed Consent for mother and baby/ies will be sought before participation.
This trial focuses on the population of preterm-born (<37 weeks of gestation) infants admitted to the Neonatal Unit.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants (born <37 weeks of gestation)
Key inclusion criteria (3 listed)
- Gestational age at birth <37 weeks.
- Admission to one of the participating units.
- Full enteral milk feeds established by suck/nasogastric tube
Key exclusion criteria (4 listed)
- Known or suspected chromosomal, genetic or metabolic abnormalities.
- Major congenital malformations
- Any intercurrent condition that precludes implementation of standard feeding protocols and requires specialized formulas or changes in standard vitamin supplementation.
- Any intercurrent condition that will interfere with the interpretation of results (renal impairment and hypothyroidism can lead to elevated tHcy and MMA, for example).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of biochemical vitamin B12 deficiency
Time frame: between 34 and 44 weeks postmenstrual age, at the time of hospital discharge
: Percentage of preterm infants with: * plasma cobalamin < 148 pmol/L. * MMA concentrations >0.26 µmol/L. * cB12 < -0.5.
1 secondary outcome
Prevalence of biochemical vitamin B12 deficiency in each gestational age group: late (34-36 weeks at birth), moderate (32-33 weeks at birth), very (28-32 weeks at birth) and extremely (<28 weeks at birth) preterm infants at the time of hospital discharge
Time frame: between 34 and 44 weeks postmenstrual age, at the time of hospital discharge
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 9 Sep 2025.
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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.
Professor Martin Warren contact
Dr Isabel Iglesias-Platas principal investigator
Norfolk and Norwich University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin B-12 Deficiency, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 4 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dr Isabel Iglesias-Platas (01603288234, isabel.iglesias-platas@nnuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of biochemical vitamin B12 deficiency (time frame: between 34 and 44 weeks postmenstrual age, at the time of hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025.