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Maternal B12 Supplementation to Improve Infant B12 Deficiency and Neurodevelopment

NCT03783104 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2019-07-22

No results posted yet for this study

Summary

Vitamin B12 plays a key role in the development and normal functioning of the brain and nervous system. Unborn and new-born infants derive their vitamin B12 stores almost entirely from maternal B12 stores. As such, infants who are born to vegetarian mothers and exclusively breast fed are at a high-risk of B12 deficiency. This is because the best sources of vitamin B12 are found in animal based or fortified foods (e.g. cheese, milk and eggs). Vitamin B12 deficiency is widely reported among antenatal mothers and children, particularly in Low and Middle Income Countries (LMICs) where these food sources are uncommon.

So far, studies have shown that antenatal vitamin B12 deficiency in mothers may be associated with poorer neurodevelopment in their children. Furthermore, vitamin B12 supplementation during pregnancy and early lactation has been shown to increase maternal, breast milk, and infant levels of vitamin B12. Although existing literature documents several studies on maternal vitamin B12 supplementation, there is a lack of research on the causative effect of maternal vitamin B12 supplementation on infant development. This project, funded by the Medical Research Council (MRC), will undertake a multi-centric nutritional trial in Nepal and India, as these are two LMICs where high incidence of vitamin B12 deficiency is reported.

Conditions

  • Child Developmental Delay
  • Child Malnutrition
  • Maternal Exposure
  • Vitamin B 12 Deficiency

Interventions

DIETARY_SUPPLEMENT

B12 Supplement

Differential doses of vitamin B 12 supplementation in a two-armed randomised controlled trial

Sponsors & Collaborators

  • Sitaram Bhartia Institute of Science and Research

    collaborator OTHER

  • Paropakar Maternity and Women's Hospital

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • Monica Lakhanpaul · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-27
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • India
  • Nepal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03783104 on ClinicalTrials.gov