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

Vitamin B 12 Deficiency Clinical Trial

— MATCOBIND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083560
• Other study ID #: MATCOBIND 2018
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: September 25, 2022

Study information

• Verified date: October 2022
• Source: Sitaram Bhartia Institute of Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: September 25, 2022
• Est. primary completion date: September 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Intervention

Drug:
• Vit B12
Vitamin B12 250mcg

Locations

Country	Name	City	State
India	Sitaram Bhartia Institute of Science and Research	New Delhi	Delhi
Nepal	Rajendra Pant	Kathmandu

Sponsors (4)

Lead Sponsor	Collaborator
Sitaram Bhartia Institute of Science and Research	Paropakar Matenity and Women's Hospital, Kathmandu, Nepal, Public Health Foundation of India, University College, London

Countries where clinical trial is conducted

India,  Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Haemoglobin of infants	Haemoglobin of infants in grams per deciliter	9 months of infant age
Other	Infant weight	Infant weight in kilograms	9 months of infant age
Other	Infant length	Infant Length in cms	9 months of infant age
Other	Infant head circumference	Infant Head circumference in cms	9 months of infant age
Primary	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	Biochemical B12 status of mother	Change in B12 status of mother between first and third trimester	At recruitment
Secondary	Biochemical B12 status of infant	Biochemical B12 status of infant at nine months postpartum	9 months of infant age