Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
600 participants
INTERVENTIONAL
2021-12-08
2029-10-15
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Cyanocobalamin
Intramuscular injection of 400 µg cobalamin to children with elevated thcy at enrollment
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.
No interventions assigned to this group
Interventions
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Cyanocobalamin
Intramuscular injection of 400 µg cobalamin to children with elevated thcy at enrollment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
1 Month
2 Months
ALL
No
Sponsors
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University of Bergen
OTHER
University of Oslo
OTHER
Inland Norway University of Applied Sciences
OTHER
Sykehuset Innlandet HF
OTHER
Responsible Party
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Principal Investigators
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Tor A Strand, M.D. / Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Sykehuset Innlandet HF
Locations
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Innlandet Hospital Trust
Lillehammer, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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U1111-1267-0112
Identifier Type: OTHER
Identifier Source: secondary_id
9305-150426
Identifier Type: -
Identifier Source: org_study_id
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