NCT03258385

Brief Summary

Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth defects and common complications (e.g. intrauterine growth restriction, neural tube defects), and possibly immune function impairment. The newborns and infants of B12-deficient mothers have low B12 stores at birth, further exacerbated by a very low concentration of B12 in breast milk that may hinder their growth and development. In regions such as Bangladesh, many women of reproductive age have inadequate B12 status, probably due to low intake of animal source food. Vitamin B12 intake and status in pregnancy and lactation is potentially insufficient to prevent impaired child development and immune function related to inadequate B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1) biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive immunity in infants; (3) neurological and cognitive function in infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

January 18, 2023

Status Verified

April 1, 2021

Enrollment Period

4.2 years

First QC Date

August 13, 2017

Last Update Submit

January 15, 2023

Conditions

Early Pregnancy

Keywords

Vitamin B12, Fortified milk, Immunity, Child development

Outcome Measures

Primary Outcomes (4)

  • Change in concentrations of biomarkers of vitamin B12 in mother-child pairs

    The investigators will determine the change in concentrations of biomarkers of B12 ( based on measurement of B12, MMA, tHcy, holoTC, cB12, folate in plasma; B12 in breast milk)

    Baseline and 6 months postpartum

  • Vaccine specific immunity in infants

    The investigators will determine the concentrations of vaccine specific IgA and IgG in plasma

    6 months

  • Cognitive, Language and Motor Composite Score

    The outcomes are measured by Bayley-III test

    12 months

  • Nuroinflammatory cytokines

    The investigators will determine the change in concentrations of EGF and TNF-α in plasma

    12 months

Study Arms (2)

Vitamin B12-fortified UHT milk

ACTIVE COMPARATOR

Supplementation group (N=74) that will receive vitamin B12 fortified UHT milk daily

Dietary Supplement: Vitamin B12 fortified UHT milk

Plain UHT milk

PLACEBO COMPARATOR

Placebo group (N=74) that will receive plain UHT milk daily

Dietary Supplement: Plain UHT milk

Interventions

Vitamin B12 fortified UHT milkDIETARY_SUPPLEMENT

Daily intake of 200 mL of UHT milk fortified with 100 µg vitamin B12

Vitamin B12-fortified UHT milk
Plain UHT milkDIETARY_SUPPLEMENT

Daily intake of 200 mL of plain UHT milk

Plain UHT milk

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. 18 - 35 y old 2. 11-14 wk pregnant (based on last menstrual period) 3. Willing to stay in Dhaka during pregnancy and remain in the area for the 12 mo following recruitment 4. Willing to be admitted in the clinic for delivery 5. Intends to exclusively or predominantly breastfeed infant until 6 mo of age

You may not qualify if:

  • \. Women with severe anemia; Hb concentration \<70 g/L 2. History or presence of systemic disease such as Diabetes mellitus, Hypertension 3. History of previous complicated pregnancies, pre-term delivery, or abortion 4. Current use of supplements containing vitamin B12 5. Children with acute illness or features suggestive of any chronic disease such as tuberculosis, any congenital anomalies such as cleft lip or palate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal and Child Health Training Institute

Dhaka, 1205, Bangladesh

Location

Related Publications (1)

  • Finkelstein JL, Fothergill A, Venkatramanan S, Layden AJ, Williams JL, Crider KS, Qi YP. Vitamin B12 supplementation during pregnancy for maternal and child health outcomes. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD013823. doi: 10.1002/14651858.CD013823.pub2.

    PMID: 38189492DERIVED

Study Officials

  • Towfida J Siddiqua, PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2017

First Posted

August 23, 2017

Study Start

September 1, 2017

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

January 18, 2023

Record last verified: 2021-04

Locations

BA(1)