NCT01126528

Brief Summary

This study is a randomized placebo-controlled trial of oral weekly vitamin D3 (cholecalciferol) supplementation during the third trimester of pregnancy among women in Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence that improving vitamin D status among pregnant women in Bangladesh will enhance the resistance of the infant offspring to infection. The aims of the study are to assess the effect of supplementation on 1) maternal and infant vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of neonatal immune function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_2 pregnancy

Timeline
Completed

Started Aug 2010

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

May 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 17, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

May 18, 2010

Last Update Submit

August 16, 2012

Conditions

Pregnancy

Keywords

Vitamin DcholecalciferolMicronutrientsDeveloping countriesBangladeshInfant, NewbornReproductive HealthInfant, Newborn, DiseasesPerinatologyImmunologycathelicidinMaternal Nutrition Physiology

Outcome Measures

Primary Outcomes (1)

  • Serum 25-hydroxyvitamin D concentration

    Biomarker of vitamin D status.

    Maternal: during 3rd trimester; Neonatal (cord blood)

Secondary Outcomes (6)

  • Serum calcium concentration

    Maternal:3rd trimester; Cord blood.

  • Urine Ca:Cr ration

    Maternal- 3rd trimester

  • Neonatal immune function

    Cord blood

  • Infant growth

    Postnatal observational follow-up phase

  • Infant and maternal postnatal vitamin D status

    Postnatal observational follow-up phase

  • +1 more secondary outcomes

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Vitamin D3 (cholecalciferol)

Dietary Supplement: Vitamin D3

Control

PLACEBO COMPARATOR

Placebo control group

Dietary Supplement: Placebo control

Interventions

Vitamin D3DIETARY_SUPPLEMENT

35,000 IU per week, started at 26-29 weeks gestation, until delivery.

Also known as: Cholecalciferol; Vigantol Oil
Vitamin D3
Placebo controlDIETARY_SUPPLEMENT

Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.

Control

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18 to \<35 years.
  • Current residence in Dhaka at a fixed address
  • Plans to have the delivery performed at the Shimantik maternity center, and to stay in Dhaka throughout the pregnancy and for at least one month past the date of delivery.
  • Gestational age of 26th to 29th (inclusive), estimated based on the first day of the last menstrual period (LMP).

You may not qualify if:

  • Use of any dietary supplement containing more than 400 IU/day (10 mcg/day) of vitamin D within the month prior to enrolment, or refusal to stop taking supplemental vitamin D at any dose after enrollment.
  • Current use of anti-convulsant or anti-mycobacterial (tuberculosis) medications.
  • Severe anemia (hemoglobin concentration \< 70 g/L).
  • Complicated medical or obstetric history that may increase the risk of preterm birth or labor/delivery complications, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, preterm labor, or multiple gestation).
  • Prior history of delivery of an infant with a major congenital anomaly, birth asphyxia, or perinatal death (stillbirth or death within first week of life).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrheal Disease Research, Bangladesh (ICDDR,B)

Dhaka, Dhaka Division, Bangladesh

Location

Related Publications (5)

  • Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

    PMID: 39077939DERIVED

  • Akhtar E, Mily A, Haq A, Al-Mahmud A, El-Arifeen S, Hel Baqui A, Roth DE, Raqib R. Prenatal high-dose vitamin D3 supplementation has balanced effects on cord blood Th1 and Th2 responses. Nutr J. 2016 Aug 9;15(1):75. doi: 10.1186/s12937-016-0194-5.

    PMID: 27506771DERIVED

  • Harrington J, Perumal N, Al Mahmud A, Baqui A, Roth DE. Vitamin D and fetal-neonatal calcium homeostasis: findings from a randomized controlled trial of high-dose antenatal vitamin D supplementation. Pediatr Res. 2014 Sep;76(3):302-9. doi: 10.1038/pr.2014.83. Epub 2014 Jun 17.

    PMID: 24937546DERIVED

  • Roth DE, Perumal N, Al Mahmud A, Baqui AH. Maternal vitamin D3 supplementation during the third trimester of pregnancy: effects on infant growth in a longitudinal follow-up study in Bangladesh. J Pediatr. 2013 Dec;163(6):1605-1611.e3. doi: 10.1016/j.jpeds.2013.07.030. Epub 2013 Aug 30.

    PMID: 23998516DERIVED

  • Roth DE, Al Mahmud A, Raqib R, Akhtar E, Perumal N, Pezzack B, Baqui AH. Randomized placebo-controlled trial of high-dose prenatal third-trimester vitamin D3 supplementation in Bangladesh: the AViDD trial. Nutr J. 2013 Apr 12;12:47. doi: 10.1186/1475-2891-12-47.

    PMID: 23587190DERIVED

MeSH Terms

Conditions

Infant, Newborn, Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Abdullah Baqui, MBBS

    JHSPH; ICDDR,B

    PRINCIPAL INVESTIGATOR

  • Daniel Roth, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

  • Rubhana Raqib, PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 19, 2010

Study Start

August 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2012

Last Updated

August 17, 2012

Record last verified: 2012-08

Locations

BA(1)