A Comparison of Two Different Doses of Maternal B12 Supplementation in Improving Infant B12 Deficiency and Neurodevelopment

NCT04083560 | Completed DMC

• 1 other identifier: MATCOBIND 2018
• Study Type: interventional
• Target: 708
• Locations: 2 countries
• Sites: 2

Brief Summary

Supplementation with Iron and folate have been part of a worldwide strategy targeting anaemia and neural tube defects for many years. However, vitamin B12 deficiency has received much less attention. High prevalence of deficiency in mothers in the antenatal period and in their infants, has been documented. Multiple case series document the neurological consequences of severe deficiency and their reversal with B-12. Trials on the subject are limited and those available have either used an ineffective dose or for a short duration. Therefore, we propose this randomised controlled trial to compare the efficacy of two different doses (pharmacological and preventive) of maternal Vitamin B-12 supplementation in improving infant B12 deficiency and neurodevelopment. We propose to undertake a multi-centric trial in India and Nepal given the high prevalence of deficiency reported from these countries and to allow a wider socio-demographic spectrum (Pay-for-service hospital catering to middle income populace from India and a free-care public hospital catering to lower income groups from Nepal). We will recruit 720 vegetarian, pregnant women from the antenatal clinics of the Indian and Nepalese centres at their first antenatal visit. Elderly primi mothers, taking B12 supplementation, multiple gestations, chronic medical conditions, anticipating moving out of the city, treated for infertility or with known psychological illnesses will be excluded. In Stage 1, recruited mothers will be randomized into 2 equal groups (360 each). Group 1-Daily 250 μg Vitamin B12 supplementation. Group 2-Daily 50 μg Vitamin B12 supplementation. B-12 will be started in 1st trimester and continue up to 6 months post-partum. In Stage 2, the birth and post-delivery course of the new-born will be monitored and documented for any morbidity. At 9 months, the neurodevelopmental, complementary feeding and home environment will be assessed and infant B12 status will be determined. The two groups will be compared for the primary (neurodevelopment) and secondary outcomes (biochemical parameters in mother and infant). The results of this study will be used to generate scientific evidence on whether B-12 should be supplemented in vegetarian pregnant women with a view to preventing B-12 deficiency and its neurodevelopmental consequences in the infant.

Conditions

Vitamin B 12 Deficiency

Outcome Measures

Primary Outcomes (1)

• Infant neurodevelopment

  Developmental Assessment Scale for Indian Infant (modified Bayleys scale) measured as average of motor and mental scores

  9 Month of infant age

Secondary Outcomes (2)

• Biochemical B12 status of mother

  At recruitment

• Biochemical B12 status of infant

  9 months of infant age

Other Outcomes (4)

• Mean Haemoglobin of infants

  9 months of infant age

• Infant weight

  9 months of infant age

• Infant length

  9 months of infant age

Study Arms (2)

Intervention group

EXPERIMENTAL

Group A Intervention: 360 pregnant women will receive 250 mcg of B-12 daily orally from 1st trimester to 6 months postpartum

Drug: Vit B12

Control group

ACTIVE COMPARATOR

Group B- Control: 360 pregnant women will receive 50 mcg of B-12 daily orally from 1st trimester to 6 months post partum

Drug: Vit B12

Interventions

Vit B12 DRUG

Vitamin B12 250mcg

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \<12 weeks gestation
• Vegetarian mothers

You may not qualify if:

• Mothers already on B12 supplementation
• Women with multiple gestation, those diagnosed with chronic medical conditions (diabetes mellitus, hypertension, heart disease, neurological disease or thyroid disease), and those who tested positive for hepatitis B, HIV or syphilis (associated with prematurity, IUGR and other neonatal morbidities which could influence neurodevelopment)
• Women who anticipate moving out of the city before/ after delivery
• Women treated for infertility
• Women with known psychological illnesses including depression

Sponsors & Collaborators

• Sitaram Bhartia Institute of Science and Research: lead
• Public Health Foundation of India: collaborator
• Paropakar Matenity and Women's Hospital, Kathmandu, Nepal: collaborator
• University College, London: collaborator

Study Sites (2)

Sitaram Bhartia Institute of Science and Research

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Rajendra Pant

Kathmandu, Nepal

Location

Related Publications (1)

• Nagpal J, Mathur MR, Rawat S, Nagrath D, Lee C, Singhal A, Heys M, Cortina Borja M, Augustin K, Gautam J, Pant R, Swabey L, Lakhanpaul M. Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial. BMJ Open. 2020 May 25;10(5):e034987. doi: 10.1136/bmjopen-2019-034987.

  PMID: 32457078 DERIVED

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant and Head of the Department

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 10, 2019
• Study Start: September 26, 2018
• Primary Completion: September 25, 2022
• Study Completion: September 25, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); NE (1)