Vitamin B12 Supplementation During Pregnancy on Cognitive Development

Summary

Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut function may decrease absorption. 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 to pregnant women on neurodevelopment and growth of their children. We also aim to measure the impact of B12 supplementation on several other outcomes.

Study design: Individually randomized double-blind placebo controlled trial in pregnant South Asian women at risk of poor vitamin B12 status. Participants will be randomized in a 1:1 ratio.

Study participants and site: 800 pregnant women from early pregnancy. Women will be enrolled as early as possible, but no later than in week 15 of pregnancy.

Intervention: Daily administration of 50 µg of vitamin B12 from early pregnancy until 6 months after birth.

Comparator: Placebo, identical to the vitamin B12 supplements.

Outcomes: Primary: (i) neurodevelopment in children measured at 6 and 12 months of age (ii) growth in children measured by weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children at 24 months (ii) gestational age at birth, (iii) fetal and infant growth measured by weight and length at birth, after 1 month and then at 3, 6, 9, and 24 months, (iv) hemoglobin concentration in children and mothers.

Relevance for programs and public health: The results from this study can suggest new dietary guidelines for South Asian women that again can lead to improved pregnancy outcomes and neurodevelopment and cognitive functioning in South Asian children.

Conditions

• Pregnancy Related
• Vitamin B 12 Deficiency
• Anemia

Interventions

DIETARY_SUPPLEMENT

cobalamin

Vitamin supplment tablet containing 50µg cobalamin

DIETARY_SUPPLEMENT

placebo

A tablet identical to the vitamin supplement but containing no vitamin B12

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.

  collaborator OTHER

• NORCE Norwegian Research Centre AS

  collaborator OTHER

• Sykehuset Innlandet HF

  collaborator OTHER

• Centre For International Health

  lead OTHER

Principal Investigators

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

• Laxman Shestha, MD · Tribhuvan University

• Ram K Chandyo, MD/PhD · Kathmandu University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-27

Primary Completion

2022-06-28

Completion

2029-12-31

Countries

• Nepal

Study Locations