Early Infant Micronutrition and Development

Recruiting now · Phase 2/Phase 3

Conditions studied: Vitamin B 12 Deficiency

In brief

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

Key facts

Study ID

NCT05005897

Run by

Sykehuset Innlandet HF

People needed

600

Starts

2021-12-08

Expected to finish

2029-10-15

Last updated by the study team

2023-04-18

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Innlandet Hospital Trust — Lillehammer, Norway (enrolling)

Full record on ClinicalTrials.gov

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