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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01126528
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : August 17, 2012
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo control Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh
Study Start Date : August 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D3
Vitamin D3 (cholecalciferol)
Dietary Supplement: Vitamin D3
35,000 IU per week, started at 26-29 weeks gestation, until delivery.
Other Name: Cholecalciferol; Vigantol Oil

Placebo Comparator: Control
Placebo control group
Dietary Supplement: Placebo control
Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.

Primary Outcome Measures :
  1. Serum 25-hydroxyvitamin D concentration [ Time Frame: Maternal: during 3rd trimester; Neonatal (cord blood) ]
    Biomarker of vitamin D status.

Secondary Outcome Measures :
  1. Serum calcium concentration [ Time Frame: Maternal:3rd trimester; Cord blood. ]
  2. Urine Ca:Cr ration [ Time Frame: Maternal- 3rd trimester ]
  3. Neonatal immune function [ Time Frame: Cord blood ]
    Selected markers of innate and adaptive immunity.

  4. Infant growth [ Time Frame: Postnatal observational follow-up phase ]
    Infant growth parameters during postnatal follow-up, up to 12 months of age

  5. Infant and maternal postnatal vitamin D status [ Time Frame: Postnatal observational follow-up phase ]
  6. Neonatal serum calcium [ Time Frame: 1st week postnatal ]
    Infant serum calcium during the first week postnatal.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).

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 identifier (NCT number): NCT01126528

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International Centre for Diarrheal Disease Research, Bangladesh (ICDDR,B)
Dhaka, Bangladesh
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
International Centre for Diarrhoeal Disease Research, Bangladesh
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Abdullah Baqui, Professor, Johns Hopkins Bloomberg School of Public Health Identifier: NCT01126528     History of Changes
Other Study ID Numbers: JHU-IRB2481
02829-5 ( Other Grant/Funding Number: Thrasher Research Fund )
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: August 17, 2012
Last Verified: August 2012

Keywords provided by Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health:
Vitamin D
Developing countries
Infant, Newborn
Reproductive Health
Infant, Newborn, Diseases
Maternal Nutrition Physiology

Additional relevant MeSH terms:
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Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents