A Phase 2/3 interventional study of Cyanocobalamin in Vitamin B 12 Deficiency, sponsored by Sykehuset Innlandet HF. Recruiting at 1 site in Norway. Open to participants aged 1 Month to 2 Months. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Sykehuset Innlandet HF · Phase 2/3, Interventional, and Treatment
Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. Poor status is also seen in affluent countries such as in Norway. Vitamin B12 is crucial for normal cell division and differentiation and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation infants on neurodevelopment. We also aim to measure the impact of B12 supplementation on several other outcomes.
Study design: Individually randomized double-blind placebo-controlled trial breastfed infants who will be assigned to a screening group (in which measurements will be obtained immediately) or a control group (in which serum will be stored and measurements done after one year).
Pregnant women will be informed about the study during their first antenatal visit at the clinic and that we will re-approach them on their 6-week visit to their public health nurse. Infants who are deficient will be treated with peroral or intramuscular injections with 400 µg cyano-cobalamin.
Infants in the control group will not be offered any intervention their blood sample will be stored for one year and then analyzed for the same nutrients as the intervention group.
Outcomes: Primary: (i) neurodevelopment in children measured at 12 months of age (ii) growth in children measured by attained weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children later in life
72 studies on the registry are indexed under Vitamin B 12 Deficiency; 10 are open to participants now.
This study's planned enrollment of 600 is above the median of 65 across 44 interventional studies indexed under Vitamin B 12 Deficiency.
Browse Vitamin B 12 Deficiency studies →Sykehuset Innlandet HF is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
From 6 weeks of age, infants will be screened for elevated plasma total homocysteine concentrations. Those who have a concentration above the defined cut-off will be treated with cobalamin (vitamin B12).
Biological: Cyanocobalamin
The control-group sample will be stored and analyzed when the child is 12 months old. Those with elevated tHcy will contribute to the control group.
Intramuscular injection of 400 µg cobalamin to children with elevated thcy at enrollment
Also known as: Vitamin B12
Neurodevelopment
Bayley Scales of Infant Development 4th edition
Time frame: 12 months of age
Prevalence of vitamin B12 deficiency
Number of children with elevated plasma homocysteine or low cobalamin
Time frame: 1-3 months of age
Prevalence of other vitamin deficiencies
Number of infants with vitamin deficiencies other than vitamin B12 deficiency
Time frame: 1-3 months of age
Neurodevelopment measured by the Ages and Stages Questionaire
Ages and Stages Questionnaire version 3 repeated throughout infancy
Time frame: 4-12 months of age
Vagal tone
Heart rate variability
Time frame: 12 months of age
Eye tracking
Visual acuity, visuospatial orientation, and attention to social cues
Time frame: 12 months of age
Neurodevelopment later in childhood
General cognitive abilities ("IQ") assessed by the Wechsler Preschool and Primary Scale of Intelligence
Time frame: 5 years
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 months after treatment with vitamin B12
Thyroid function
Infant thyroid function measured by the concentration of the hormones TSH, T3, and T4
Time frame: 12 months of age
Plan to share: Yes — We plan to share data with other researchers.
Supporting information: Study protocol, Sap
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Sykehuset Innlandet HF