Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART) (NCT00920621) | Clinical Trial Compass
CompletedPhase 3
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
United States876 participantsStarted 2009-09
Plain-language summary
Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.
Who can participate
Age range
18 Years – 39 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since the VDAART trial was a completed Phase 3 study looking at whether taking vitamin D during pregnancy could reduce a child's risk of asthma or recurrent wheezing in the first three years of life, can you walk me through what the results actually showed and whether the findings are strong enough to change what you'd recommend for my pregnancy?
2The trial aimed to get mothers' vitamin D blood levels up to at least 30 ng/mL by the third trimester — do you know what my current vitamin D level is, and does it fall in a range where supplementation during pregnancy might be worth discussing?
3Given that this was a Phase 3 randomized trial, which is a late-stage design meant to confirm effectiveness and safety, how confident are you in the evidence it produced, and are there any safety considerations about higher-dose vitamin D supplementation during pregnancy that I should weigh?
4Since the trial tracked children for asthma and wheezing outcomes over the first three years of life, is there follow-up research beyond that window that you think I should know about before deciding whether prenatal vitamin D supplementation makes sense for my situation?
5If my child already has a family history of asthma, does the evidence from this trial change how you'd think about vitamin D supplementation during pregnancy compared to other preventive steps we could take?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Asthma or Recurrent Wheeze in First 3 Years of Life
Timeframe: First 3 years of life.
2
Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.