Vitamin B 12 DeficiencyMATCOBINDNCT04083560
A Comparison of Two Different Doses of Maternal B12 Supplementation in Improving Infant B12 Deficiency and Neurodevelopment
A study testing Vit B12 in people with Vitamin B 12 Deficiency, run by Sitaram Bhartia Institute of Science and Research at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin B 12 Deficiency
- What is being tested?
- Vit B12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Sep 2018to 25 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- <12 weeks gestation
- Vegetarian mothers
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
India1 site
Sitaram Bhartia Institute of Science and Research
New Delhi, National Capital Territory of Delhi, 110016
About this study
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.
- Conditions
- Vitamin B 12 Deficiency
- Being tested
- Vit B12
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit B12Drug
Vitamin B12 250mcg
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group A Intervention: 360 pregnant women will receive 250 mcg of B-12 daily orally from 1st trimester to 6 months postpartum Receives: Drug: Vit B12 |
| Control group | Active comparator | Group B- Control: 360 pregnant women will receive 50 mcg of B-12 daily orally from 1st trimester to 6 months post partum Receives: Drug: Vit B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant neurodevelopment
Developmental Assessment Scale for Indian Infant (modified Bayleys scale) measured as average of motor and mental scores
Measured: 9 Month of infant age
Secondary outcomes (2)
Biochemical B12 status of mother
Change in B12 status of mother between first and third trimester
Measured: At recruitment
Biochemical B12 status of infant
Biochemical B12 status of infant at nine months postpartum
Measured: 9 months of infant age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start26 Sep 2018
- Primary completion25 Sep 2022
- Study completion25 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin B 12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sitaram Bhartia Institute of Science and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Foundation of India, Paropakar Matenity and Women's Hospital, Kathmandu, Nepal, University College, London
- Responsible party
- Principal investigator, Dr Jitender Nagpal, Sitaram Bhartia Institute of Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083560
- Sponsor's protocol ID
- MATCOBIND 2018
- Acronym
- MATCOBIND
- Status last verified
- Oct 2022
- First submitted
- 2 Sep 2019
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32457078
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Different Doses of Maternal B12 Supplementation in Improving Infant B12 Deficiency and Neurodevelopment
- ClinicalTrials.gov ID
- NCT04083560
- Acronym / sponsor ID
- MATCOBIND / MATCOBIND 2018
- Conditions
- Vitamin B 12 Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Sitaram Bhartia Institute of Science and ResearchUniversity, hospital or other
- Collaborators
- Public Health Foundation of India, Paropakar Matenity and Women's Hospital, Kathmandu, Nepal, University College, London
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 25 Sep 2022 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Vit B12Group A Intervention: 360 pregnant women will receive 250 mcg of B-12 daily orally from 1st trimester to 6 months postpartum |
| Control group | Active comparator | Drug: Vit B12Group B- Control: 360 pregnant women will receive 50 mcg of B-12 daily orally from 1st trimester to 6 months post partum |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- <12 weeks gestation
- Vegetarian mothers
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vit B12Vitamin B12 250mcg | Drug | Control group, Intervention group |
Primary outcome
Infant neurodevelopment
Time frame: 9 Month of infant age
Developmental Assessment Scale for Indian Infant (modified Bayleys scale) measured as average of motor and mental scores
2 secondary outcomes
Biochemical B12 status of mother
Time frame: At recruitment
Biochemical B12 status of infant
Time frame: 9 months of infant age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 32457078Nagpal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vit B12 in people with Vitamin B 12 Deficiency, run by Sitaram Bhartia Institute of Science and Research at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant neurodevelopment (time frame: 9 Month of infant age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04083560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.