Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial (AViDD-2)

This study has been completed.
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01126528
First received: May 18, 2010
Last updated: August 16, 2012
Last verified: August 2012

May 18, 2010
August 16, 2012
August 2010
May 2011   (final data collection date for primary outcome measure)
Serum 25-hydroxyvitamin D concentration [ Time Frame: Maternal: during 3rd trimester; Neonatal (cord blood) ] [ Designated as safety issue: No ]
Biomarker of vitamin D status.
Same as current
Complete list of historical versions of study NCT01126528 on ClinicalTrials.gov Archive Site
  • Serum calcium concentration [ Time Frame: Maternal:3rd trimester; Cord blood. ] [ Designated as safety issue: Yes ]
  • Urine Ca:Cr ration [ Time Frame: Maternal- 3rd trimester ] [ Designated as safety issue: Yes ]
  • Neonatal immune function [ Time Frame: Cord blood ] [ Designated as safety issue: No ]
    Selected markers of innate and adaptive immunity.
  • Infant growth [ Time Frame: Postnatal observational follow-up phase ] [ Designated as safety issue: No ]
    Infant growth parameters during postnatal follow-up, up to 12 months of age
  • Infant and maternal postnatal vitamin D status [ Time Frame: Postnatal observational follow-up phase ] [ Designated as safety issue: No ]
  • Neonatal serum calcium [ Time Frame: 1st week postnatal ] [ Designated as safety issue: No ]
    Infant serum calcium during the first week postnatal.
  • Serum calcium concentration [ Time Frame: Maternal:3rd trimester; Cord blood. ] [ Designated as safety issue: Yes ]
  • Urine Ca:Cr ration [ Time Frame: Maternal- 3rd trimester ] [ Designated as safety issue: Yes ]
  • Neonatal immune function [ Time Frame: Cord blood ] [ Designated as safety issue: No ]
    Selected markers of innate and adaptive immunity.
Not Provided
Not Provided
 
Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial
The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh

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.

The primary aims of this study are:

AIM #1 - To assess the effect of weekly antenatal administration of oral vitamin D3 (875 mcg/week = 35,000 IU week ≈ 5,000 IU per day) started in the third trimester (26-29 weeks gestation) on maternal vitamin D status and fetal-neonatal vitamin D status (cord blood), in comparison to a placebo control supplement.

AIM #2 - To demonstrate the maternal and fetal safety of weekly maternal antenatal (second and third-trimester) vitamin D supplementation at a dose of 875 mcg/week by monitoring maternal serum calcium, urinary calcium excretion, cord blood calcium concentration, and newborn clinical parameters.

AIM #3 - To measure the effect of antenatal vitamin D supplementation on selected biomarkers of fetal-neonatal immune function in cord blood: in vitro stimulated cord blood mononuclear cell (CBMC) LL-37 expression, gene expression related to inflammatory and immunoregulatory pathways, Th1/Th2 cytokine secretion, and bactericidal properties.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pregnancy
  • Dietary Supplement: Vitamin D3
    35,000 IU per week, started at 26-29 weeks gestation, until delivery.
    Other Name: Cholecalciferol; Vigantol Oil
  • Dietary Supplement: Placebo control
    Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.
  • Experimental: Vitamin D3
    Vitamin D3 (cholecalciferol)
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: Control
    Placebo control group
    Intervention: Dietary Supplement: Placebo control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
May 2012
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).
Female
18 Years to 34 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT01126528
JHU-IRB2481, 02829-5
Yes
Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
International Centre for Diarrhoeal Disease Research, Bangladesh
Principal Investigator: 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
Johns Hopkins Bloomberg School of Public Health
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP