Early Infant Micronutrition and Development (RART)

April 14, 2023 updated by: Sykehuset Innlandet HF

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).

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
      • Lillehammer, Norway, 2615
        • Recruiting
        • Innlandet Hospital Trust
        • Contact:
        • Contact:
          • Tor A Strand, phd
          • Phone Number: +4790971086
          • Email: tors@me.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopment
Time Frame: 12 months of age
Bayley Scales of Infant Development 4th edition
12 months of age
Prevalence of vitamin B12 deficiency
Time Frame: 1-3 months of age
Number of children with elevated plasma homocysteine or low cobalamin
1-3 months of age
Prevalence of other vitamin deficiencies
Time Frame: 1-3 months of age
Number of infants with vitamin deficiencies other than vitamin B12 deficiency
1-3 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopment measured by the Ages and Stages Questionaire
Time Frame: 4-12 months of age
Ages and Stages Questionnaire version 3 repeated throughout infancy
4-12 months of age
Vagal tone
Time Frame: 12 months of age
Heart rate variability
12 months of age
Eye tracking
Time Frame: 12 months of age
Visual acuity, visuospatial orientation, and attention to social cues
12 months of age
Neurodevelopment later in childhood
Time Frame: 5 years
General cognitive abilities ("IQ") assessed by the Wechsler Preschool and Primary Scale of Intelligence
5 years
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
3 months after treatment with vitamin B12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyroid function
Time Frame: 12 months of age
Infant thyroid function measured by the concentration of the hormones TSH, T3, and T4
12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Innlandet HF

Collaborators

University of Oslo
University of Bergen
Inland Norway University of Applied Sciences

Investigators

  • Principal Investigator: Tor A Strand, M.D. / Ph.D., Sykehuset Innlandet HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2021

Primary Completion (Anticipated)

October 15, 2025

Study Completion (Anticipated)

October 15, 2029

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9305-150426
  • U1111-1267-0112 (Other Identifier: World Health Organization)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share data with other researchers.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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