NCT05005897: RART

Early Infant Micronutrition and Development

Recruiting now Phase 2, PHASE3 Last updated 18 April 2023

What this trial tests

Phase 2, PHASE3 trial testing Cyanocobalamin in Vitamin B 12 Deficiency in 600 participants. Currently enrolling.

Timeline

8 December 2021

Primary endpoint
15 October 2025

15 October 2029

Quick facts

Lead sponsor	Sykehuset Innlandet HF
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	600
Start date	8 December 2021
Primary completion	15 October 2025
Estimated completion	15 October 2029
Sites	1 location across Norway

Drugs / interventions tested

• Cyanocobalamin (CYANOCOBALAMIN) — full drug profile →

Conditions studied

• Vitamin B 12 Deficiency — all drugs for Vitamin B 12 Deficiency →

Sponsor

Sykehuset Innlandet HF — full company profile →

Who can join

Adults 1 Month to 2 Months, any sex, with Vitamin B 12 Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vitamin B₁₂ status in infancy and the effect of a vitamin B₁₂ injection in infants with subclinical vitamin B₁₂ deficiency: study protocol for a register-based randomised controlled trial.
   Bakken KS, Kvestad I, Bjørkevoll SMG, Solvik BS, et al · · 2023 · cited 3× · PMID 37080624 · DOI 10.1136/bmjopen-2022-069102
2. Infant vitamin B12 status and its predictors - cross-sectional baseline results from an ongoing randomized controlled trial.
   Bjørkevoll SMG, O'Keeffe M, Konijnenberg C, Solvik BS, et al · · 2025 · cited 1× · PMID 40609749 · DOI 10.1016/j.ajcnut.2025.06.029