A Comparison of Two Different Doses of Maternal B12 Supplementation in Improving Infant B12 Deficiency and Neurodevelopment (MATCOBIND)
Primary Purpose
Vitamin B 12 Deficiency
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vit B12
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin B 12 Deficiency
Eligibility Criteria
Inclusion Criteria:
- <12 weeks gestation
Vegetarian mothers
Exclusion Criteria:
- 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
Sites / Locations
- Sitaram Bhartia Institute of Science and Research
- Rajendra Pant
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Group A Intervention: 360 pregnant women will receive 250 mcg of B-12 daily orally from 1st trimester to 6 months postpartum
Group B- Control: 360 pregnant women will receive 50 mcg of B-12 daily orally from 1st trimester to 6 months post partum
Outcomes
Primary Outcome Measures
Infant neurodevelopment
Developmental Assessment Scale for Indian Infant (modified Bayleys scale) measured as average of motor and mental scores
Secondary Outcome Measures
Biochemical B12 status of mother
Change in B12 status of mother between first and third trimester
Biochemical B12 status of infant
Biochemical B12 status of infant at nine months postpartum
Full Information
NCT ID
NCT04083560
First Posted
September 2, 2019
Last Updated
October 24, 2022
Sponsor
Sitaram Bhartia Institute of Science and Research
Collaborators
Public Health Foundation of India, Paropakar Matenity and Women's Hospital, Kathmandu, Nepal, University College, London
1. Study Identification
Unique Protocol Identification Number
NCT04083560
Brief Title
A Comparison of Two Different Doses of Maternal B12 Supplementation in Improving Infant B12 Deficiency and Neurodevelopment
Acronym
MATCOBIND
Official Title
A Comparison of Two Different Doses of Maternal B12 Supplementation in Improving Infant B12 Deficiency and Neurodevelopment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
September 25, 2022 (Actual)
Study Completion Date
September 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sitaram Bhartia Institute of Science and Research
Collaborators
Public Health Foundation of India, Paropakar Matenity and Women's Hospital, Kathmandu, Nepal, University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B 12 Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
708 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Group A Intervention: 360 pregnant women will receive 250 mcg of B-12 daily orally from 1st trimester to 6 months postpartum
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Group B- Control: 360 pregnant women will receive 50 mcg of B-12 daily orally from 1st trimester to 6 months post partum
Intervention Type
Drug
Intervention Name(s)
Vit B12
Intervention Description
Vitamin B12 250mcg
Primary Outcome Measure Information:
Title
Infant neurodevelopment
Description
Developmental Assessment Scale for Indian Infant (modified Bayleys scale) measured as average of motor and mental scores
Time Frame
9 Month of infant age
Secondary Outcome Measure Information:
Title
Biochemical B12 status of mother
Description
Change in B12 status of mother between first and third trimester
Time Frame
At recruitment
Title
Biochemical B12 status of infant
Description
Biochemical B12 status of infant at nine months postpartum
Time Frame
9 months of infant age
Other Pre-specified Outcome Measures:
Title
Mean Haemoglobin of infants
Description
Haemoglobin of infants in grams per deciliter
Time Frame
9 months of infant age
Title
Infant weight
Description
Infant weight in kilograms
Time Frame
9 months of infant age
Title
Infant length
Description
Infant Length in cms
Time Frame
9 months of infant age
Title
Infant head circumference
Description
Infant Head circumference in cms
Time Frame
9 months of infant age
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
<12 weeks gestation
Vegetarian mothers
Exclusion Criteria:
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
Facility Information:
Facility Name
Sitaram Bhartia Institute of Science and Research
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110016
Country
India
Facility Name
Rajendra Pant
City
Kathmandu
Country
Nepal
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32457078
Citation
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.
Results Reference
derived
Learn more about this trial
A Comparison of Two Different Doses of Maternal B12 Supplementation in Improving Infant B12 Deficiency and Neurodevelopment
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