Early Infant Micronutrition and Development
ConditionVitamin B 12 Deficiency
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-2
SponsorSykehuset Innlandet HF
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Availability of informed verbal consent
Plan to reside in the defined study area for the next 12 months
Mothers intend to breastfeed their children for at least 8 months, and exclusively for 4 months
Disqualifiers
Severe systemic illness requiring hospitalization
Growth retardation
Severe congenital malformations
Plasma cobalamin concentration <148 pmol/L (These children will be treated for vitamin B12 deficiency and not included in the RCT, but will be included in the cohort design)
Trial design
Design model
Parallel
Treatments tested in this trial
Cyanocobalamin
Biological/VaccineIntramuscular injection of 400 µg cobalamin to children with elevated thcy at enrollment
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Screening - treatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Neurodevelopment
Bayley Scales of Infant Development 4th edition
Time frame
12 months of age2
Prevalence of vitamin B12 deficiency
Number of children with elevated plasma homocysteine or low cobalamin
Time frame
1-3 months of age3
Prevalence of other vitamin deficiencies
Number of infants with vitamin deficiencies other than vitamin B12 deficiency
Time frame
1-3 months of ageSecondary outcomes
1
Neurodevelopment measured by the Ages and Stages Questionaire
Ages and Stages Questionnaire version 3 repeated throughout infancy
Time frame
4-12 months of age2
Vagal tone
Heart rate variability
Time frame
12 months of age3
Eye tracking
Visual acuity, visuospatial orientation, and attention to social cues
Time frame
12 months of age4
Neurodevelopment later in childhood
General cognitive abilities ("IQ") assessed by the Wechsler Preschool and Primary Scale of Intelligence
Time frame
5 yearsOther outcomes
1
Thyroid function
Infant thyroid function measured by the concentration of the hormones TSH, T3, and T4
Time frame
12 months of ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sykehuset Innlandet HF
Lead sponsor
University of Bergen
Collaborator
University of Oslo
Collaborator
Inland Norway University of Applied Sciences
Collaborator
Source ClinicalTrials.gov