Status:

COMPLETED

Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)

Lead Sponsor:

Brigham and Women's Hospital

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Asthma

Eligibility:

FEMALE

18-39 years

Phase:

PHASE3

Brief Summary

Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.

Detailed Description

Asthma is one of the leading causes of morbidity in children with 60% of all cases diagnosed by age 3. Thus, finding factors that can lead to prevention of this disease would be of great public health...

Eligibility Criteria

Inclusion

  • Personal history of asthma, eczema, allergic rhinitis or a history of asthma, eczema, allergic rhinitis in the biological father of the child
  • Gestational age between 10 and 18 weeks at the time of randomization
  • Maternal age between 18 and 39 years
  • Not a current smoker
  • English or Spanish speaking
  • Intent to participate for the full 4 years (through Pregnancy and then until the 3rd birthday of the child)

Exclusion

  • Not meeting inclusion criteria
  • Gestational age greater than 18 weeks
  • Presence of chronic medical conditions
  • Taking vitamin D supplements containing more than 2000 IU/day of vitamin D3
  • Multiple gestation pregnancy (twins, triplets)
  • Pregnancy achieved by assisted reproduction techniques (e.g., IUI, IVF)

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2023

Estimated Enrollment :

876 Patients enrolled

Trial Details

Trial ID

NCT00920621

Start Date

September 1 2009

End Date

August 1 2023

Last Update

February 20 2025

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

Robert Zeiger, MD

San Diego, California, United States

2

George O'Connor, MD

Boston, Massachusetts, United States

3

Leonard Bacharier, MD

St Louis, Missouri, United States