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Vitamin B12, Neurodevelopment and Growth in Nepal (BeLive)

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ClinicalTrials.gov Identifier: NCT02272842
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : July 17, 2018
Sponsor:
Collaborators:
Tribhuvan University, Nepal
Uni Health, Uni Research, Norway
Information provided by (Responsible Party):
Centre For International Health

Brief Summary:

Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is crucial for normal cell division and is necessary for brain growth as well as for the maintenance of its normal function. Deficiency is also associated with impaired growth. In a previous study, we demonstrated that vitamin B12 administration over a period of six months enhanced growth, and scores on a neuro-developmental test in young Indian children. However, the overall effect was small and, for the developmental scores significant only in those that were malnourished at the start of the study.

Our findings need to be verified in trials targeting younger, malnourished children and with longer supplementation time.

Hypothesis: This proposed study will test three hypotheses; to measure to what extent 2 recommended daily allowances (RDA) of vitamin B12 administration for one year to stunted children improves; 1) growth, 2) neurodevelopment, and 3) hemoglobin concentration.

Study design: Randomized placebo-controlled trial. Half of the children will receive a paste containing vitamin B12, the other half the same paste but without vitamin B12.

Study participants and site: 600 malnourished infants in Bhaktapur municipality in Nepal. In this population we have demonstrated that vitamin B12 deficiency and poor growth is common in early childhood.

Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months

Data: The main outcomes of this study are scores on developmental assessments tools and growth measured every month for 12 months.


Condition or disease Intervention/treatment Phase
Development Vitamin Deficiency Malnutrition Dietary Supplement: Vitamin B12 Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin B12 Supplementation in Nepali Infants on Growth and Development
Actual Study Start Date : April 20, 2015
Actual Primary Completion Date : February 28, 2018
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arm Intervention/treatment
Experimental: Vitamin B12
A paste containing vitamin B12 2µg per 10 mL administered every day. The paste also contains 1 RDA of several other vitamins. The paste is produced by Compact (Norway / India)
Dietary Supplement: Vitamin B12
Vitamin B12 in a multivitamin paste.
Other Name: Cobalamin

Placebo Comparator: Placebo
A paste containing no vitamin administered every day. The paste also contains 1 RDA of several vitamins, but no vitamin B12. The paste is produced by Compact (Norway / India)
Dietary Supplement: Vitamin B12
Vitamin B12 in a multivitamin paste.
Other Name: Cobalamin




Primary Outcome Measures :
  1. Neurodevelopment [ Time Frame: 12 months ]
    Neurodevelopment measured by the Bayley Scales of Infant Development version 3

  2. Growth [ Time Frame: 12 months ]
    Change in weigh for age and length for age z scores from study start to end study.

  3. Hemoglobin concentration [ Time Frame: 12 months ]
    Change in hemoglobin concentration from baseline to end study.


Secondary Outcome Measures :
  1. Growth velocity over the first six months of supplementation [ Time Frame: 6 months ]
    length and weight growth velocity z scores the first 6 months of supplementation

  2. Predictors for neurodevelopment in young Nepali children [ Time Frame: 12 months ]
    Using the collected data, identify morbidity, stimulation, nutrition, socioeconomic related predictors for neurodevelopment.

  3. Identify subgroups of children who benefit from vitamin B12 supplementation [ Time Frame: 12 months ]
    Based on selected baseline variables we will identify subgroups who benefit from vitamin B12 supplementation

  4. The effect of vitamin B12 supplementation on markers of vitamin B status [ Time Frame: 12 months ]
    We will draw a blood sample at study start and at end study to measure to what extent vitamin status is altered.

  5. Neurodevelopment measured by other tools. [ Time Frame: 12 months ]
    We will measure to what extent vitamin B12 supplementation improves neurodevelopment measured by other tools such as the Ages and Stages Questionnaire (version 3) and the NEPSY II test.

  6. Immediate adverse effects of the intervention [ Time Frame: 12 months ]
    We will investigate side effects such as pain, nausea, vomiting, regurgitation, allergic reactions and others after each dose of the intervention.


Other Outcome Measures:
  1. Extended followup: Neurodevelopment [ Time Frame: 3 years ]
    If resources allow, we will follow the cohort beyond the planned (and funded) project period and measure neurodevelopment using appropriate tests such as the Wechsler tests

  2. Surrogate markers for Neurodevelopment [ Time Frame: 2 years ]
    If funding allows, measure other markers related to neurodevelopment such as Brain Derived Neurotrophic Factor



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Ages Eligible for Study:   6 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 to 11 months
  • Stunted
  • Availability of informed verbal consent
  • Plan to reside in the area for the next 12 months

Exclusion Criteria:

  • Severe systemic illness requiring hospitalization
  • Severe malnutrition, i.e. weight for height < -3 z of the WHO standard for this age group. For ethical reasons these children require micronutrient supplementation and adequate medical care.
  • Lack of consent
  • Taking B vitamin supplements that include vitamin B12.
  • Severe anemia (Hb < 7 g/dL). This would be a temporary exclusion and the children will be enrolled if they are successfully treated.
  • Ongoing acute infection with fever or infection that requires medical treatment. This would be a temporary exclusion and the children will be enrolled after recovery.

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): NCT02272842


Locations
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Nepal
Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan
Bhaktapur, Nepal, P.O.Box 40
Sponsors and Collaborators
Centre For International Health
Tribhuvan University, Nepal
Uni Health, Uni Research, Norway
Investigators
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Principal Investigator: Prakash S Shrestha, MD Tribhuvan University, Nepal
Principal Investigator: Sudha Basnet, MD/PhD Tribhuvan University, Nepal
Principal Investigator: Tor A Strand, MD/PhD Innlandet Hospital Trust / University of Bergen

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre For International Health
ClinicalTrials.gov Identifier: NCT02272842     History of Changes
Other Study ID Numbers: 808734
U1111-1161-5187 ( Other Identifier: WHO )
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Centre For International Health:
Nepal
Cobalamin
Neurodevelopment
Stunting
Growth

Additional relevant MeSH terms:
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Malnutrition
Avitaminosis
Nutrition Disorders
Deficiency Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics