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Vitamin B12 Supplementation to Improve B12 Status and Child Development

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ClinicalTrials.gov Identifier: NCT03258385
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Early Pregnancy Dietary Supplement: Vitamin B12 fortified UHT milk Dietary Supplement: Plain UHT milk Not Applicable

Detailed Description:
The investigators aim to conduct a double-blind, randomized trial, to investigate the effects of B12-fortified milk on maternal and infant B12 status, immune function and child development. Pregnant women (n=148) will be randomized to receive B12-fortified milk (100 μg/day) or milk without fortification. The daily supplementation beginning at the baseline visit (GW 11-14) will continue until 6 mo-postpartum. Biomarkers of B12 status will be measured in mothers (GW 11-14 and 6-mo postpartum) and infants (3 and 6-mo). Infant development (6 and 12-mo) will be evaluated by Bayley Scales of Infant and Toddler Development. Immune responses will be measured in infant at 3 and 6-mo. Data on socioeconomic status, dietary diversity, and anthropometric indices will be recorded at baseline. Additional tests in mothers include screening for H. pylori and plasma gastrin.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Effects of Vitamin B12 Fortified Milk Supplementation During Pregnancy and 6 Month Postpartum to Improve B12 Status and Child Development
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vitamin B12-fortified UHT milk
Supplementation group (N=74) that will receive vitamin B12 fortified UHT milk daily
Dietary Supplement: Vitamin B12 fortified UHT milk
Daily intake of 200 mL of UHT milk fortified with 100 µg vitamin B12

Placebo Comparator: Plain UHT milk
Placebo group (N=74) that will receive plain UHT milk daily
Dietary Supplement: Plain UHT milk
Daily intake of 200 mL of plain UHT milk




Primary Outcome Measures :
  1. Change in concentrations of biomarkers of vitamin B12 in mother-child pairs [ Time Frame: Baseline and 6 months postpartum ]
    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)

  2. Vaccine specific immunity in infants [ Time Frame: 6 months ]
    The investigators will determine the concentrations of vaccine specific IgA and IgG in plasma

  3. Cognitive, Language and Motor Composite Score [ Time Frame: 12 months ]
    The outcomes are measured by Bayley-III test

  4. Nuroinflammatory cytokines [ Time Frame: 12 months ]
    The investigators will determine the change in concentrations of EGF and TNF-α in plasma



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. 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

Exclusion Criteria:

1. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258385


Contacts
Contact: Towfida J Siddiqua, PhD +8801718722147 towfida@icddrb.org
Contact: Rubhana Raqib, PhD +8801713040942 rubhana@icddrb.org

Locations
Bangladesh
Maternal and Child Health Training Institute Not yet recruiting
Dhaka, Bangladesh, 1205
Contact: Ishrat Jahan, MBBS, MPH    +8801713009029      
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of California, Davis
Investigators
Principal Investigator: Towfida J Siddiqua, PhD International Centre for Diarrhoeal Disease Research, Bangladesh

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03258385     History of Changes
Other Study ID Numbers: PR-16003
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Vitamin B12, Fortified milk, Immunity, Child development

Additional relevant MeSH terms:
Vitamins
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics