Phase 3
N=1,752
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00920621 ↗Enrolled (actual)
1,752
Serious AEs
15.0%
Results posted
Jul 2017
Primary outcome: Primary: Asthma or Recurrent Wheeze in First 3 Years of Life — 98; 120; 307; 281 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vitamin D 3 cholecalciferol (Dietary_supplement); Vitamin D3 (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma or Recurrent Wheeze in First 3 Years of Life |
98; 120; 307; 281 | — |
| PRIMARY Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. |
289; 133; 97; 258 | — |
| SECONDARY Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit. |
414; 452 | — |
| SECONDARY Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit. |
29.3; 30.1 | — |
| SECONDARY Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life. |
83; 89; 322; 312 | — |
| SECONDARY Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life. |
222; 276 | — |
| SECONDARY Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit. |
21.3; 21.5 | — |
| SECONDARY Any Allergic Sensitization in the Child's First 3 Years of Life. |
146; 144; 132; 117 | — |
| SECONDARY Mass Spec Vitamin D Value From Cord Blood at Delivery |
28.2; 19.1 | — |
| SECONDARY Sphingolipid Profile |
0.34; 0.32; 0.39; 0.37; 0.31; 0.30 | — |
| SECONDARY Sphingolipid Profile |
0.34; 0.32; 0.39; 0.37; 0.31; 0.30 | — |
| SECONDARY Child 17q21 Genotype |
93; 78; 152; 161; 66; 68 | — |
| SECONDARY Fecal Microbiome Profile |
10787; 10773; 13443; 14024; 11709; 11635 | — |
| SECONDARY Proportion of Participants With Late-Pregnancy 25(OH)D Below Clinically Relevant Thresholds, by Maternal BMI Category |
6; 30; 12; 29; 20; 50 | — |
Summary
Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00920621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.