NCT04083560: MATCOBIND

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

Completed NA Last updated 26 October 2022

What this trial tests

NA trial testing Vit B12 in Vitamin B 12 Deficiency in 708 participants. Completed in 25 September 2022.

Timeline

26 September 2018

Primary endpoint
25 September 2022

25 September 2022

Quick facts

Lead sponsor	Sitaram Bhartia Institute of Science and Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	708
Start date	26 September 2018
Primary completion	25 September 2022
Estimated completion	25 September 2022
Sites	2 locations across Nepal, India

Drugs / interventions tested

• Vit B12 — full drug profile →

Conditions studied

• Vitamin B 12 Deficiency — all drugs for Vitamin B 12 Deficiency →

Sponsor

Sitaram Bhartia Institute of Science and Research

Who can join

Adults 18 to 35, female only, with Vitamin B 12 Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of nutrients in human neurodevelopment and their potential to prevent neurodevelopmental adversity.
   Heland S, Fields N, Ellery SJ, Fahey M, et al · · 2022 · cited 24× · PMID 36483929 · DOI 10.3389/fnut.2022.992120
2. Efficacy of maternal B<sub>12</sub> supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial.
   Nagpal J, Mathur MR, Rawat S, Nagrath D, et al · · 2020 · cited 5× · PMID 32457078 · DOI 10.1136/bmjopen-2019-034987