An observational study in Vitamin B-12 Deficiency, sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust · Observational
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.
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.
73 studies on the registry are indexed under Vitamin B 12 Deficiency; 8 are open to participants now.
This study's planned enrollment of 40 is below the median of 200 across 27 observational studies indexed under Vitamin B 12 Deficiency.
Browse Vitamin B 12 Deficiency studies →Norfolk and Norwich University Hospitals NHS Foundation Trust is the lead sponsor of 30 studies on the registry; 9 are open to participants now.
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Preterm infants (born \<37 weeks of gestation)
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Exclusion Criteria:
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.
Time frame: between 34 and 44 weeks postmenstrual age, at the time of hospital discharge
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.
Time frame: between 34 and 44 weeks postmenstrual age, at the time of hospital discharge
To explore levels of other metabolites related to B12/folate pathways in preterm infants (including vitamin B6 and copper/zinc).
Blood concentrations of vitamins B1, B2 and B6 (assessed by plasma levels of thiamine pyrophosphate, flavin adenine dinucleotide and pyridoxal 5'-phosphate, respectively).
Time frame: between 34 and 44 weeks postmenstrual age, at the time of hospital discharge
Explore levels of B vitamins in human milk of mothers delivering prematurely
Measurement of B1, B2, B6, folate and B12 in milk of mothers delivering prematurely. Correlations between concentration in breast milk and calculated total vitamin intake and infant blood levels will be also explored.
Time frame: between 34 and 44 weeks postmenstrual age, at the time of hospital discharge
Start is estimated for Sep 2025; primary completion for Jan 2026, 4 months later.
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Norfolk and Norwich University Hospitals NHS Foundation Trust