Vitamin B 12 Deficiency
Conditions
Keywords
Nutrition, Vitamins, Breastfeeding, Infant, Neurodevelopment, Growth, Clinical trial
Brief summary
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
Interventions
BIOLOGICALCyanocobalamin
Intramuscular injection of 400 µg cobalamin to children with elevated thcy at enrollment
Sponsors
University of Bergen
University of Oslo
Inland Norway University of Applied Sciences
Sykehuset Innlandet HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 2 Months
Healthy volunteers
No
Inclusion criteria
1. Availability of informed verbal consent 2. Plan to reside in the defined study area for the next 12 months 3. Mothers intend to breastfeed their children for at least 8 months, and exclusively for 4 months
Exclusion criteria
1. Severe systemic illness requiring hospitalization 2. Growth retardation 3. Severe congenital malformations 4. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of other vitamin deficiencies | 1-3 months of age | Number of infants with vitamin deficiencies other than vitamin B12 deficiency |
| Neurodevelopment | 12 months of age | Bayley Scales of Infant Development 4th edition |
| Prevalence of vitamin B12 deficiency | 1-3 months of age | Number of children with elevated plasma homocysteine or low cobalamin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eye tracking | 12 months of age | Visual acuity, visuospatial orientation, and attention to social cues |
| Adverse events | 3 months after treatment with vitamin B12 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Neurodevelopment later in childhood | 5 years | General cognitive abilities (IQ) assessed by the Wechsler Preschool and Primary Scale of Intelligence |
| Neurodevelopment measured by the Ages and Stages Questionaire | 4-12 months of age | Ages and Stages Questionnaire version 3 repeated throughout infancy |
| Vagal tone | 12 months of age | Heart rate variability |
Other
| Measure | Time frame | Description |
|---|---|---|
| Thyroid function | 12 months of age | Infant thyroid function measured by the concentration of the hormones TSH, T3, and T4 |
Countries
Norway
Contacts
Primary ContactCarolien Konijnenberg, Ph.D
Backup ContactKjersti S Bakken, Ph.D.
Outcome results
None listed