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Early Infant Micronutrition and Development (RART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05005897
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : December 13, 2021
Sponsor:
Collaborators:
University of Bergen
University of Oslo
Inland Norway University of Applied Sciences
Information provided by (Responsible Party):
Sykehuset Innlandet HF

Brief 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


Condition or disease Intervention/treatment Phase
Vitamin B 12 Deficiency Biological: Cyanocobalamin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 8, 2021
Estimated Primary Completion Date : October 15, 2025
Estimated Study Completion Date : October 15, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arm Intervention/treatment
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).
Biological: Cyanocobalamin
Intramuscular injection of 400 µg cobalamin to children with elevated thcy at enrollment
Other Name: 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.



Primary Outcome Measures :
  1. Neurodevelopment [ Time Frame: 12 months of age ]
    Bayley Scales of Infant Development 4th edition

  2. Prevalence of vitamin B12 deficiency [ Time Frame: 1-3 months of age ]
    Number of children with elevated plasma homocysteine or low cobalamin

  3. Prevalence of other vitamin deficiencies [ Time Frame: 1-3 months of age ]
    Number of infants with vitamin deficiencies other than vitamin B12 deficiency


Secondary Outcome Measures :
  1. Neurodevelopment measured by the Ages and Stages Questionaire [ Time Frame: 4-12 months of age ]
    Ages and Stages Questionnaire version 3 repeated throughout infancy

  2. Vagal tone [ Time Frame: 12 months of age ]
    Heart rate variability

  3. Eye tracking [ Time Frame: 12 months of age ]
    Visual acuity, visuospatial orientation, and attention to social cues

  4. Neurodevelopment later in childhood [ Time Frame: 5 years ]
    General cognitive abilities ("IQ") assessed by the Wechsler Preschool and Primary Scale of Intelligence

  5. Adverse events [ Time Frame: 3 months after treatment with vitamin B12 ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Other Outcome Measures:
  1. Thyroid function [ Time Frame: 12 months of age ]
    Infant thyroid function measured by the concentration of the hormones TSH, T3, and T4



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Ages Eligible for Study:   1 Month to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Availability of informed verbal consent
  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:

  1. Severe systemic illness requiring hospitalization
  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05005897


Contacts
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Contact: Carolien Konijnenberg, Ph.D +47 61 28 74 94 carolien.konijnenberg@inn.no
Contact: Kjersti S Bakken, Ph.D. +47 957 81 349 Kjersti.Sletten.Bakken@sykehuset-innlandet.no

Locations
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Norway
Innlandet Hospital Trust Recruiting
Lillehammer, Norway, 2615
Contact: Kjersti S Bakken, phd    +4795781349    kjerstisbakken@gmail.com   
Contact: Tor A Strand, phd    +4790971086    tors@me.com   
Sponsors and Collaborators
Sykehuset Innlandet HF
University of Bergen
University of Oslo
Inland Norway University of Applied Sciences
Investigators
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Principal Investigator: Tor A Strand, M.D. / Ph.D. Sykehuset Innlandet HF
Publications:

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Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT05005897    
Other Study ID Numbers: 9305-150426
U1111-1267-0112 ( Other Identifier: World Health Organization )
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: December 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share data with other researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available not later than 5 years after the study have completed enrollment and the first year of follow-up of all children.
Access Criteria: Data available on request. In order to meet ethical requirements for the use of confidential patient data, requests must be approved by Regional Committee for Medical and Health Research Ethics in Norway.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sykehuset Innlandet HF:
Nutrition
Vitamins
Breastfeeding
Infant
Neurodevelopment
Growth
Clinical trial
Additional relevant MeSH terms:
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Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin B 12
Hydroxocobalamin
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex
Hematinics