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

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

Sponsors

Lead Sponsor: Sitaram Bhartia Institute of Science and Research

Collaborator: Public Health Foundation of India
Paropakar Matenity and Women's Hospital, Kathmandu, Nepal
University College, London

Source Sitaram Bhartia Institute of Science and Research
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.

Overall Status Recruiting
Start Date September 26, 2018
Completion Date September 25, 2021
Primary Completion Date September 25, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Infant neurodevelopment 9 Month of infant age
Secondary Outcome
Measure Time Frame
Biochemical B12 status of mother At recruitment
Biochemical B12 status of infant 9 months of infant age
Enrollment 720
Condition
Intervention

Intervention Type: Drug

Intervention Name: Vit B12

Description: Vitamin B12 250mcg

Eligibility

Criteria:

Inclusion Criteria:

- <12 weeks gestation

Vegetarian mothers

Exclusion Criteria:

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)

3. Women who anticipate moving out of the city before/ after delivery

4. Women treated for infertility

5. Women with known psychological illnesses including depression

Gender: Female

Gender Based: Yes

Gender Description: Pregnant women

Minimum Age: 18 Years

Maximum Age: 35 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Jitender Nagpal

Phone: +919871799011

Phone Ext.: +919871799011

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Sitaram Bhartia Institute of Science and Research | New Delhi, Delhi, 110016, India Recruiting Jitender Nagpal, MD +919871799011 [email protected] Jitender Nagpal, MD Principal Investigator
Rajendra Pant | Kathmandu, Nepal Recruiting Jageshwor Gautam [email protected]
Location Countries

India

Nepal

Verification Date

February 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Sitaram Bhartia Institute of Science and Research

Investigator Full Name: Dr Jitender Nagpal

Investigator Title: Senior Consultant and Head of the Department

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention group

Type: Experimental

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

Label: Control group

Type: Active Comparator

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

Acronym MATCOBIND
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov