Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART) (VDAART)
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ClinicalTrials.gov Identifier: NCT00920621 |
Recruitment Status :
Active, not recruiting
First Posted : June 15, 2009
Results First Posted : July 14, 2017
Last Update Posted : July 20, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Dietary Supplement: Vitamin D 3 cholecalciferol Dietary Supplement: Vitamin D3 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 876 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART) |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | January 21, 2015 |
Estimated Study Completion Date : | February 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Vitamin D treatment
vitamin D treatment plus prenatal multivitamins
|
Dietary Supplement: Vitamin D 3 cholecalciferol
Dosage form oral Dosage 4000IU Vitamin D 3 cholecalciferol
Other Names:
Dietary Supplement: Vitamin D3 4000 IU of vitamin D3 administered orally once a day during pregnancy |
Placebo Comparator: placebo
placebo plus prenatal multivitamins
|
Dietary Supplement: Vitamin D3
4000 IU of vitamin D3 administered orally once a day during pregnancy |
- Asthma or Recurrent Wheeze in First 3 Years of Life [ Time Frame: First 3 years of life. ]
Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months.
*For some variables the "negative" count incorporates "negative and indeterminate."
- Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. [ Time Frame: 32-38 weeks gestation ]Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy
- Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit. [ Time Frame: 3 years ]Child positive-specific IgE tests from blood collection at 3 year visit.
- Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit. [ Time Frame: 1 year visit ]Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit.
- Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life. [ Time Frame: Child's first 3 years of life. ]
Parental report of physician diagnosis of eczema with rash in typical distribution in the child's first 3 years of life ascertained from questionnaires administered every 3 months.
*For some variables the "negative" count incorporates "negative and indeterminate."
- Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life. [ Time Frame: Child's first 3 years of life. ]Parental report of physician diagnosis of lower respiratory tract infection (LRI) in the child's first 3 years of life. LRI defined as physician diagnosed bronchitis, bronchiolitis, croup, or pneumonia ascertained from questionnaires administered every 3 months.
- Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit. [ Time Frame: Blood collection at childs' 3 year visit. ]Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit.
- Any Allergic Sensitization in the Child's First 3 Years of Life. [ Time Frame: Child's first 3 years of life. ]
Any allergic sensitization in the child's first 3 years of life.
*For some variables the "negative" count incorporates "negative and indeterminate."
- Mass Spec Vitamin D Value From Cord Blood at Delivery [ Time Frame: Blood collection at delivery ]Mass Spec Vitamin D value from cord blood at delivery
- Sphingolipid Profile [ Time Frame: 1 year ]Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year one visit.
- Sphingolipid Profile [ Time Frame: 3 years ]Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year three visit.
- Child 17q21 Genotype [ Time Frame: 3 years ]Genotype at the rs12936231 SNP
- Fecal Microbiome Profile [ Time Frame: Mother at 32-38 weeks gestation, Child's first 6 years of life ]We extracted DNA and sequenced the bacterial 16S V4 hyper-variable region. The average number of 16S region reads sequenced per participant is provided here. Prior evidence suggests that read counts of at least 1,000 are adequate for 16S fecal microbiome profiling (Reference: Momozawa Y, et cal. Characterization of bacteria in biopsies of colon and stools by high throughput sequencing of the V2 region of bacterial 16S rRNA gene in human. PLoS One. 2011 Feb 10;6(2):e16952.)
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Ages Eligible for Study: | 18 Years to 39 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920621
United States, California | |
Robert Zeiger, MD | |
San Diego, California, United States | |
United States, Massachusetts | |
George O'Connor, MD | |
Boston, Massachusetts, United States | |
United States, Missouri | |
Leonard Bacharier, MD | |
Saint Louis, Missouri, United States |
Principal Investigator: | Scott T Weiss | Brigham and Women's Hospital |
Responsible Party: | Scott T. Weiss, Principal Investigator, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00920621 |
Other Study ID Numbers: |
655 5U01HL091528-03 ( U.S. NIH Grant/Contract ) HL091528-01A1 |
First Posted: | June 15, 2009 Key Record Dates |
Results First Posted: | July 14, 2017 |
Last Update Posted: | July 20, 2023 |
Last Verified: | June 2023 |
Asthma Vitamin D Randomized Control Trial |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Vitamin D Ergocalciferols Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |