Antenatal Vitamin D3 Supplementation in Bangladesh: Randomized Controlled Trial

Pregnancy Clinical Trial

— AViDD-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126528
• Other study ID #: JHU-IRB2481
• Secondary ID: 02829-5
• Status: Completed
• Phase: Phase 2
• First received: May 18, 2010
• Last updated: August 16, 2012
• Start date: August 2010
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• Vitamin D3
35,000 IU per week, started at 26-29 weeks gestation, until delivery.
• Placebo control
Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrheal Disease Research, Bangladesh (ICDDR,B)	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25-hydroxyvitamin D concentration	Biomarker of vitamin D status.	Maternal: during 3rd trimester; Neonatal (cord blood)	No
Secondary	Serum calcium concentration		Maternal:3rd trimester; Cord blood.	Yes
Secondary	Urine Ca:Cr ration		Maternal- 3rd trimester	Yes
Secondary	Neonatal immune function	Selected markers of innate and adaptive immunity.	Cord blood	No
Secondary	Infant growth	Infant growth parameters during postnatal follow-up, up to 12 months of age	Postnatal observational follow-up phase	No
Secondary	Infant and maternal postnatal vitamin D status		Postnatal observational follow-up phase	No
Secondary	Neonatal serum calcium	Infant serum calcium during the first week postnatal.	1st week postnatal	No