NCT00641862

Brief Summary

This study is a randomized, double-blind trial among 300 pregnant Indian women in order to determine the effectiveness of vitamin B12 supplementation in improving maternal B12 status. Secondary aims for this trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care, including routine supplementation with iron and folate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
366

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Dec 2008

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

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

October 17, 2016

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

March 17, 2008

Results QC Date

August 22, 2016

Last Update Submit

July 13, 2020

Conditions

Pregnancy

Keywords

PregnancyMaternal Nutritional StatusVitamin B12

Outcome Measures

Primary Outcomes (1)

  • Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester

    from 1st to 3rd trimester

Secondary Outcomes (11)

  • Cognitive Scale, Bayley Scales of Infant Development, 3rd Edition

    9 months

  • Receptive Language Scale, Bayley Scales of Infant Development, 3rd Edition

    9 months

  • Expressive Language Scale, Bayley Scales of Infant Development, 3rd Edition

    9 months

  • Fine Motor Scale, Bayley Scales of Infant Development, 3rd Edition

    9 months

  • Gross Motor Scale, Bayley Scales of Infant Development, 3rd Edition

    9 months

  • +6 more secondary outcomes

Study Arms (2)

Vitamin B12

ACTIVE COMPARATOR

Vitamin B12

Dietary Supplement: Vitamin B12

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Vitamin B12DIETARY_SUPPLEMENT

Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Vitamin B12
PlaceboOTHER

Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women at or before 14 weeks gestational age.

You may not qualify if:

  • Women who anticipate moving outside of the study area before study completion
  • Those with twin or multiple pregnancies
  • Those who test positive for hepatitis B (HepBSAg), HIV or Syphilis (VDRL)
  • Those taking vitamin supplements in addition to folate and iron
  • Those with a serious pre-existing medical condition, defined as conditions that require chronic or daily medical therapy such as connective tissue diseases, hypertension not related to pregnancy, inflammatory bowel disease, active tuberculosis, symptomatic heart disease, and insulin dependent diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. John's Medical Research Institute, St. John's National Academy of Health Sciences

Bangalore, Karnataka, 560-034, India

Location

Related Publications (8)

  • Muthayya S, Dwarkanath P, Mhaskar M, Mhaskar R, Thomas A, Duggan C, Fawzi WW, Bhat S, Vaz M, Kurpad A. The relationship of neonatal serum vitamin B12 status with birth weight. Asia Pac J Clin Nutr. 2006;15(4):538-43.

    PMID: 17077072BACKGROUND

  • Muthayya S, Kurpad AV, Duggan CP, Bosch RJ, Dwarkanath P, Mhaskar A, Mhaskar R, Thomas A, Vaz M, Bhat S, Fawzi WW. Low maternal vitamin B12 status is associated with intrauterine growth retardation in urban South Indians. Eur J Clin Nutr. 2006 Jun;60(6):791-801. doi: 10.1038/sj.ejcn.1602383. Epub 2006 Jan 11.

    PMID: 16404414BACKGROUND

  • 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

  • Srinivasan K, Thomas S, Anand S, Jayachandra M, Thomas T, Strand TA, Kurpad AV, Duggan CP. Vitamin B-12 Supplementation during Pregnancy and Early Lactation Does Not Affect Neurophysiologic Outcomes in Children Aged 6 Years. J Nutr. 2020 Jul 1;150(7):1951-1957. doi: 10.1093/jn/nxaa123.

    PMID: 32470975DERIVED

  • Anand S, Thomas S, Jayachandra M, Thomas T, Strand TA, Kurpad AV, Duggan CP, Srinivasan K. Effects of maternal B12 supplementation on neurophysiological outcomes in children: a study protocol for an extended follow-up from a placebo randomised control trial in Bangalore, India. BMJ Open. 2019 Feb 19;9(2):e024426. doi: 10.1136/bmjopen-2018-024426.

    PMID: 30782904DERIVED

  • Winje BA, Kvestad I, Krishnamachari S, Manji K, Taneja S, Bellinger DC, Bhandari N, Bisht S, Darling AM, Duggan CP, Fawzi W, Hysing M, Kumar T, Kurpad AV, Sudfeld CR, Svensen E, Thomas S, Strand TA. Does early vitamin B12 supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania. BMJ Open. 2018 Feb 22;8(2):e018962. doi: 10.1136/bmjopen-2017-018962.

    PMID: 29472265DERIVED

  • Duggan C, Srinivasan K, Thomas T, Samuel T, Rajendran R, Muthayya S, Finkelstein JL, Lukose A, Fawzi W, Allen LH, Bosch RJ, Kurpad AV. Vitamin B-12 supplementation during pregnancy and early lactation increases maternal, breast milk, and infant measures of vitamin B-12 status. J Nutr. 2014 May;144(5):758-64. doi: 10.3945/jn.113.187278. Epub 2014 Mar 5.

    PMID: 24598885DERIVED

  • Lukose A, Ramthal A, Thomas T, Bosch R, Kurpad AV, Duggan C, Srinivasan K. Nutritional factors associated with antenatal depressive symptoms in the early stage of pregnancy among urban South Indian women. Matern Child Health J. 2014 Jan;18(1):161-170. doi: 10.1007/s10995-013-1249-2.

    PMID: 23440491DERIVED

MeSH Terms

Interventions

Vitamin B 12

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Christopher Duggan
Organization
Harvard T.H. Chan School of Public Health
christopher.duggan@childrens.harvard.edu
617-355-7612

Study Officials

  • Christopher P Duggan, MD, MPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

  • Anura Kurpad, MBBS, PhD

    St. John's Research Institute

    PRINCIPAL INVESTIGATOR

  • Krishnamachari Srinivasan, MD

    St. John's Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in the Department of Nutrition

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

July 28, 2020

Results First Posted

October 17, 2016

Record last verified: 2020-07

Locations

IN(1)