A study to evaluate the utility of Vitamin B-12 supplementation of pregnant women in improving the brain development of their infants

A randomised controlled trial to compare two different doses of maternal B12 supplementation in improving infant B12 deficiency and neurodevelopment - MATCOBIND

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/07/015048

Enrollment

720

Registered

2018-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Group A Intervention: 180 pregnant women will receive 250 mcg of B-12 daily orally from 1st trimester to 6 months postpartum Control Intervention1: Group B- Control: 180 pregnant women

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women Vegetarian mothers

Exclusion criteria

Exclusion criteria: Elderly primi mother ( >35 years) 1. Mothers already on B12 supplementation 2. 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) 1. Women who anticipate moving out of the city before/ after delivery 2. Women treated for infertility 3. Women with known psychological illnesses including depression

Design outcomes

Primary

Measure	Time frame
Neurodevelopment scores at 9 month age of infantsTimepoint: May 2020 to June 2021	—

Secondary

Measure	Time frame
Biochemical B12 status of mother and babyTimepoint: June 2021	—

Countries

India, Nepal

Contacts

Public ContactDr Jitender Nagpal

Sitaram Bhartia Institute of Science and Research

jitendernagpal@gmail.com

Outcome results