Vitamin B12 Status in Infancy and the Effect of Providing Vitamin B12 to Infants With Signs of Suboptimal Vitamin B12 Status - a Registry-based, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 2 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Innlandet Hospital Trust
RECRUITING
Lillehammer
Contact Information
Primary
Carolien Konijnenberg, Ph.D
carolien.konijnenberg@inn.no
+47 61 28 74 94
Backup
Kjersti S Bakken, Ph.D.
Kjersti.Sletten.Bakken@sykehuset-innlandet.no
+47 957 81 349
Time Frame
Start Date: 2021-12-08
Estimated Completion Date: 2029-10-15
Participants
Target number of participants: 600
Treatments
Experimental: Screening - treatment
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).
No_intervention: Control
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.
Sponsors
Collaborators: University of Bergen, University of Oslo, Inland Norway University of Applied Sciences
Leads: Sykehuset Innlandet HF

This content was sourced from clinicaltrials.gov