Vitamin B12, Neurodevelopment and Growth in Nepal

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.

Conditions

• Development
• Vitamin Deficiency
• Malnutrition

Interventions

DIETARY_SUPPLEMENT

Vitamin B12

Vitamin B12 in a multivitamin paste.

Sponsors & Collaborators

• Tribhuvan University, Nepal

  collaborator OTHER

• NORCE Norwegian Research Centre AS

  collaborator OTHER

• Centre For International Health

  lead OTHER

Principal Investigators

• Prakash S Shrestha, MD · Tribhuvan University, Nepal

• Tor A Strand, MD/PhD · Innlandet Hospital Trust / University of Bergen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

11 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-20

Primary Completion

2018-02-28

Completion

2024-12-28

Countries

• Nepal

Study Locations