A Comparison of Two Different Doses of Maternal B12 Supplementation in

Status Completed

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Vitamin B 12 Deficiency

Clinical Trial Details

NCT number	NCT04083560
Study type	Interventional
Source	Sitaram Bhartia Institute of Science and Research
Contact
Status	Completed
Phase	N/A
Start date	September 26, 2018
Completion date	September 25, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06100146` - Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls	N/A
Completed	`NCT04632771` - Nutritional Status and Bouillon Use in Northern Ghana
Active, not recruiting	`NCT03853304` - Quadruple Fortified Salt Trial in India	N/A
Completed	`NCT03437824` - Effects of Vitamin B12 Treatment in Singers	Early Phase 1
Active, not recruiting	`NCT05315843` - Cobalamin Supply and Metabolism in Healthy Children From Birth to the Age of 12 Months and in Their Mothers (Cbl_Neo)
Completed	`NCT05614960` - Dried Purple Laver (Nori) as a Food Source of Vitamin B12 in Vegetarians	N/A
Completed	`NCT03444155` - Natural Versus Synthetic Vitamin B Complexes in Human	N/A
Enrolling by invitation	`NCT05389618` - Dietary Challenges in the Population of Nursing Homes' Residents
Completed	`NCT01832129` - Vitamin B12 Acceptance and Biomarker Response Study	Phase 4
Completed	`NCT03365583` - The Impact of Vitamin B12 Deficiency on Infant Gut Microbiota
Active, not recruiting	`NCT03071666` - Vitamin B12 Supplementation During Pregnancy on Cognitive Development	Phase 2/Phase 3
Active, not recruiting	`NCT05426395` - Vitamin B12 Dose Escalation Trial in Pregnancy	Phase 1
Completed	`NCT00710138` - Cobalamin Status in Young Children With Developmental Delay	N/A
Completed	`NCT03284840` - Adults Nutrition as a Protective or Health-risk Factor
Completed	`NCT01476007` - Oral/Intramuscular B12 to Treat Cobalamin Deficiency	N/A
Completed	`NCT03447275` - The Vitamin B Status in Type 2 Diabetes (VITA) Study
Completed	`NCT02860338` - COMPARATIVE EFFECTIVENESS OF MCI and DEMENTIA TREATMENTS IN A COMMUNITY-BASED DEMENTIA PRACTICE	N/A
Active, not recruiting	`NCT05178407` - Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana	N/A
Completed	`NCT05993962` - Effect of Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status in Older Adults	N/A
Not yet recruiting	`NCT06046703` - Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms