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)
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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