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AzTrials

Vitamin B 12 DeficiencyPhase 2/3RARTNCT05005897

Early Infant Micronutrition and Development

A Phase 2/3 study testing Cyanocobalamin in people with Vitamin B 12 Deficiency, run by Sykehuset Innlandet HF at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 month to 2 months
Conditions the study is for
Vitamin B 12 Deficiency
What is being tested?
Cyanocobalamin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteNorway
Study dates
8 Dec 2021to 15 Oct 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 2 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carolien Konijnenberg, Ph.D contact

+47 61 28 74 94

carolien.konijnenberg@inn.no

Kjersti S Bakken, Ph.D. contact

+47 957 81 349

Kjersti.Sletten.Bakken@sykehuset-innlandet.no

Norway1 site, 1 recruiting

  • Innlandet Hospital Trust

    Lillehammer, 2615

    Kjersti S Bakken, phd, +4795781349, kjerstisbakken@gmail.com

    Tor A Strand, phd, +4790971086, tors@me.com

    Recruiting

Other trials in Norway

About this study

Official title: 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

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).

Read more

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

Being tested
Cyanocobalamin
Keywords
Nutrition, Vitamins, Breastfeeding, Infant, Neurodevelopment, Growth, Clinical trial
Medical subject headings
Vitamin B 12 Deficiency, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyanocobalaminBiological

    Also called Vitamin B12

    Intramuscular injection of 400 µg cobalamin to children with elevated thcy at enrollment

Study groups in NCT05005897
Study groupRoleWhat they receive
Screening - treatmentExperimentalFrom 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).
Receives: Biological: Cyanocobalamin
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurodevelopment

    Bayley Scales of Infant Development 4th edition

    Measured: 12 months of age

  2. Prevalence of vitamin B12 deficiency

    Number of children with elevated plasma homocysteine or low cobalamin

    Measured: 1-3 months of age

  3. Prevalence of other vitamin deficiencies

    Number of infants with vitamin deficiencies other than vitamin B12 deficiency

    Measured: 1-3 months of age

Secondary outcomes (5)

  1. Neurodevelopment measured by the Ages and Stages Questionaire

    Ages and Stages Questionnaire version 3 repeated throughout infancy

    Measured: 4-12 months of age

  2. Vagal tone

    Heart rate variability

    Measured: 12 months of age

  3. Eye tracking

    Visual acuity, visuospatial orientation, and attention to social cues

    Measured: 12 months of age

  4. Neurodevelopment later in childhood

    General cognitive abilities ("IQ") assessed by the Wechsler Preschool and Primary Scale of Intelligence

    Measured: 5 years

  5. Adverse events

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 3 months after treatment with vitamin B12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start8 Dec 2021
  3. Primary completion15 Oct 2025 (estimated)
  4. Study completion15 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05005897
Sponsor's protocol ID
9305-150426
Other IDs
U1111-1267-0112
Acronym
RART
Status last verified
Apr 2023
First submitted
9 Aug 2021
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to share data with other researchers.

Publications

  • Hay G, Johnston C, Whitelaw A, Trygg K, Refsum H. Folate and cobalamin status in relation to breastfeeding and weaning in healthy infants. Am J Clin Nutr. 2008 Jul;88(1):105-14. doi: 10.1093/ajcn/88.1.105.

    PubMed 18614730

  • Torsvik I, Ueland PM, Markestad T, Bjorke-Monsen AL. Cobalamin supplementation improves motor development and regurgitations in infants: results from a randomized intervention study. Am J Clin Nutr. 2013 Nov;98(5):1233-40. doi: 10.3945/ajcn.113.061549. Epub 2013 Sep 11.

    PubMed 24025626

  • Dror DK, Allen LH. Effect of vitamin B12 deficiency on neurodevelopment in infants: current knowledge and possible mechanisms. Nutr Rev. 2008 May;66(5):250-5. doi: 10.1111/j.1753-4887.2008.00031.x.

    PubMed 18454811

  • Kvestad I, Taneja S, Kumar T, Hysing M, Refsum H, Yajnik CS, Bhandari N, Strand TA; Folate and Vitamin B12 Study Group. Vitamin B12 and Folic Acid Improve Gross Motor and Problem-Solving Skills in Young North Indian Children: A Randomized Placebo-Controlled Trial. PLoS One. 2015 Jun 22;10(6):e0129915. doi: 10.1371/journal.pone.0129915. eCollection 2015.

    PubMed 26098427

  • Bjorke-Monsen AL. Is exclusive breastfeeding ensuring an optimal micronutrient status and psychomotor development in infants? Clin Biochem. 2014 Jun;47(9):714. doi: 10.1016/j.clinbiochem.2014.05.022. Epub 2014 May 17. No abstract available.

    PubMed 24845709

  • Forssman L, Ashorn P, Ashorn U, Maleta K, Matchado A, Kortekangas E, Leppanen JM. Eye-tracking-based assessment of cognitive function in low-resource settings. Arch Dis Child. 2017 Apr;102(4):301-302. doi: 10.1136/archdischild-2016-310525. Epub 2016 Aug 22.

    PubMed 27551061

  • Graziano P, Derefinko K. Cardiac vagal control and children's adaptive functioning: a meta-analysis. Biol Psychol. 2013 Sep;94(1):22-37. doi: 10.1016/j.biopsycho.2013.04.011. Epub 2013 May 4.

    PubMed 23648264

  • Strand TA, Taneja S, Ueland PM, Refsum H, Bahl R, Schneede J, Sommerfelt H, Bhandari N. Cobalamin and folate status predicts mental development scores in North Indian children 12-18 mo of age. Am J Clin Nutr. 2013 Feb;97(2):310-7. doi: 10.3945/ajcn.111.032268. Epub 2013 Jan 2.

    PubMed 23283502

  • Bjorkevoll SMG, O'Keeffe M, Konijnenberg C, Solvik BS, Sodal AF, Kaldenbach S, McCann A, Ueland PM, Kvestad I, Ersvaer E, Holten-Andersen MN, Bakken KS, Strand TA. Infant vitamin B12 status and its predictors - cross-sectional baseline results from an ongoing randomized controlled trial. Am J Clin Nutr. 2025 Sep;122(3):803-810. doi: 10.1016/j.ajcnut.2025.06.029. Epub 2025 Jul 1.

    PubMed 40609749

  • Bakken KS, Kvestad I, Bjorkevoll SMG, Solvik BS, Kaldenbach S, McCann A, Holten-Andersen MN, Ersvaer E, Konijnenberg C, Strand TA. 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. BMJ Open. 2023 Apr 20;13(4):e069102. doi: 10.1136/bmjopen-2022-069102.

    PubMed 37080624

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cyanocobalamin in people with Vitamin B 12 Deficiency, run by Sykehuset Innlandet HF at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carolien Konijnenberg, Ph.D (+47 61 28 74 94, carolien.konijnenberg@inn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurodevelopment (time frame: 12 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05005897, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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