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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 : January 28, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Scott T. Weiss, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Asthma
Interventions Dietary Supplement: Vitamin D 3 cholecalciferol
Dietary Supplement: Vitamin D3
Enrollment 876
Recruitment Details VDAART was a randomized, double-blind, placebo-controlled trial. Enrollment began October 2009 and completed follow-up January 2015 in 3 medical centers in the United Stated. 881 pregnant women age 18-39 at high risk for having children with asthma were randomized at 10-18 weeks gestation. 5 did not meet inclusion criteria and were removed.
Pre-assignment Details  
Arm/Group Title Vitamin D Treatment (Mothers) Placebo (Mothers) Vitamin D Treatment (Offspring) Placebo (Offspring)
Hide Arm/Group Description Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D). Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy). Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D) Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control"
Period Title: Overall Study
Started 440 436 440 436
Completed 386 391 405 401
Not Completed 54 45 35 35
Reason Not Completed
Lost to Follow-up             16             17             19             21
Fetal/neonatal deaths             16             14             16             14
Blood sample not collected             22             14             0             0
Arm/Group Title Vitamin D Treatment (Mothers) Placebo (Mothers) Vitamin D Treatment (Children) Placebo (Children) Total
Hide Arm/Group Description Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D) Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy). Children of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D). Children of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy). Total of all reporting groups
Overall Number of Baseline Participants 440 436 405 401 1682
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 440 participants 436 participants 405 participants 401 participants 1682 participants
27.5  (5.5) 27.3  (5.6) 0  (0) 0  (0) 27.4  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 440 participants 436 participants 405 participants 401 participants 1682 participants
Female
440
 100.0%
436
 100.0%
204
  50.4%
181
  45.1%
1261
  75.0%
Male
0
   0.0%
0
   0.0%
201
  49.6%
220
  54.9%
421
  25.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 440 participants 436 participants 405 participants 401 participants 1682 participants
Black
190
  43.2%
190
  43.6%
199
  49.1%
191
  47.6%
770
  45.8%
White Hispanic
59
  13.4%
61
  14.0%
53
  13.1%
51
  12.7%
224
  13.3%
White non-Hispanic
114
  25.9%
116
  26.6%
82
  20.2%
79
  19.7%
391
  23.2%
Other
77
  17.5%
69
  15.8%
71
  17.5%
80
  20.0%
297
  17.7%
1.Primary Outcome
Title Asthma or Recurrent Wheeze in First 3 Years of Life
Hide Description

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."

Time Frame First 3 years of life.
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed 405 401
Measure Type: Count of Participants
Unit of Measure: Participants
Children positive
98
  24.2%
120
  29.9%
Children negative
307
  75.8%
281
  70.1%
2.Primary Outcome
Title Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.
Hide Description Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy
Time Frame 32-38 weeks gestation
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
Overall Number of Participants Analyzed 386 391
Measure Type: Count of Participants
Unit of Measure: Participants
25(OH)D level of ≥ 30 ng/mL , women positive
289
  74.9%
133
  34.0%
25(OH)D level of ≥ 30 ng/mL , women negative
97
  25.1%
258
  66.0%
3.Secondary Outcome
Title Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.
Hide Description Child positive-specific IgE tests from blood collection at 3 year visit.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed 278 263
Overall Number of Units Analyzed
Type of Units Analyzed: Completed tests
3876 3651
Measure Type: Number
Unit of Measure: Positive-specific IgE tests
414 452
4.Secondary Outcome
Title Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.
Hide Description Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit.
Time Frame 1 year visit
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed 322 309
Mean (Standard Deviation)
Unit of Measure: ng/mL
29.3  (9.2) 30.1  (10.8)
5.Secondary Outcome
Title Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life.
Hide Description

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."

Time Frame Child's first 3 years of life.
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed 405 401
Measure Type: Count of Participants
Unit of Measure: Participants
Children positive
83
  20.5%
89
  22.2%
Children negative
322
  79.5%
312
  77.8%
6.Secondary Outcome
Title Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.
Hide Description 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.
Time Frame Child's first 3 years of life.
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed 405 401
Measure Type: Number
Unit of Measure: Number of lower respiratory infections
222 276
7.Secondary Outcome
Title Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.
Hide Description Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit.
Time Frame Blood collection at childs' 3 year visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed 289 271
Mean (Standard Deviation)
Unit of Measure: ng/mL
21.3  (10.4) 21.5  (8.5)
8.Secondary Outcome
Title Any Allergic Sensitization in the Child's First 3 Years of Life.
Hide Description

Any allergic sensitization in the child's first 3 years of life.

*For some variables the "negative" count incorporates "negative and indeterminate."

Time Frame Child's first 3 years of life.
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D.
Overall Number of Participants Analyzed 278 261
Measure Type: Count of Participants
Unit of Measure: Participants
Any sensitization
146
  52.5%
144
  55.2%
No sensitization
132
  47.5%
117
  44.8%
9.Secondary Outcome
Title Mass Spec Vitamin D Value From Cord Blood at Delivery
Hide Description Mass Spec Vitamin D value from cord blood at delivery
Time Frame Blood collection at delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
Overall Number of Participants Analyzed 303 316
Mean (Standard Deviation)
Unit of Measure: ng/mL
28.2  (12.4) 19.1  (9.7)
10.Secondary Outcome
Title Sphingolipid Profile
Hide Description Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year one visit.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D
Overall Number of Participants Analyzed 211 202
Mean (Standard Deviation)
Unit of Measure: relative abundance (no units)
sphinganine-1-phosphate 0.32  (0.10) 0.32  (0.10)
sphinganine 0.33  (0.20) 0.31  (0.18)
phosphoethanolamine 0.33  (0.13) 0.34  (0.13)
sphingosine 0.34  (0.17) 0.33  (0.17)
sphingosine-1-phosphate 0.31  (0.06) 0.32  (0.06)
11.Secondary Outcome
Title Sphingolipid Profile
Hide Description Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year three visit.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D
Overall Number of Participants Analyzed 179 174
Mean (Standard Deviation)
Unit of Measure: relative abundance (no units)
sphinganine-1-phosphate 0.34  (0.12) 0.32  (0.12)
sphinganine 0.39  (0.20) 0.37  (0.20)
phosphoethanolamine 0.31  (0.11) 0.30  (0.11)
sphingosine 0.38  (0.19) 0.37  (0.19)
sphingosine-1-phosphate 0.31  (0.07) 0.30  (0.08)
12.Secondary Outcome
Title Child 17q21 Genotype
Hide Description Genotype at the rs12936231 SNP
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Some measures have missing data due to collection, technical, and processing issues.
Arm/Group Title Vitamin D Treatment Placebo
Hide Arm/Group Description:
Children of mother's assigned 4400 IU Vitamin D
Children of mother's assigned 400 IU Vitamin D
Overall Number of Participants Analyzed 311 307
Measure Type: Count of Participants
Unit of Measure: Participants
CC
93
  29.9%
78
  25.4%
GC
152
  48.9%
161
  52.4%
GG
66
  21.2%
68
  22.1%
Time Frame From the point mothers entered the study until 2 years post delivery.
Adverse Event Reporting Description Maternal and offspring SAEs were collected via a monthly electronic record review and via quarterly follow-up calls.
 
Arm/Group Title Vitamin D Treatment (Mothers) Placebo (Mothers) Vitamin D Treatment (Offspring) Placebo (Offspring)
Hide Arm/Group Description Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D). Mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy). Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D). Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control" (providing the current standard of care during pregnancy).
All-Cause Mortality
Vitamin D Treatment (Mothers) Placebo (Mothers) Vitamin D Treatment (Offspring) Placebo (Offspring)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/440 (0.00%)      1/436 (0.23%)      3/440 (0.68%)      3/436 (0.69%)    
Hide Serious Adverse Events
Vitamin D Treatment (Mothers) Placebo (Mothers) Vitamin D Treatment (Offspring) Placebo (Offspring)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/440 (17.05%)      77/436 (17.66%)      58/440 (13.18%)      52/436 (11.93%)    
General disorders         
Hospitalization   32/440 (7.27%)  42 32/436 (7.34%)  45 0/440 (0.00%)  0 0/436 (0.00%)  0
Postpartum Hospitalization   7/440 (1.59%)  10 6/436 (1.38%)  8 0/440 (0.00%)  0 0/436 (0.00%)  0
Maternal Death   0/440 (0.00%)  0 1/436 (0.23%)  1 0/440 (0.00%)  0 0/436 (0.00%)  0
NICU  [1]  0/440 (0.00%)  0 0/436 (0.00%)  0 29/440 (6.59%)  36 18/436 (4.13%)  28
Pregnancy, puerperium and perinatal conditions         
HELLP   2/440 (0.45%)  2 1/436 (0.23%)  1 0/440 (0.00%)  0 0/436 (0.00%)  0
Preeclampsia   34/440 (7.73%)  36 37/436 (8.49%)  38 0/440 (0.00%)  0 0/436 (0.00%)  0
Pre-term delivery <32 weeks gestation   0/440 (0.00%)  0 0/436 (0.00%)  0 3/440 (0.68%)  5 7/436 (1.61%)  11
Major fetal or congenital anomaly   0/440 (0.00%)  0 0/436 (0.00%)  0 10/440 (2.27%)  17 13/436 (2.98%)  14
Still birth or intrauterine fetal death   0/440 (0.00%)  0 0/436 (0.00%)  0 13/440 (2.95%)  13 11/436 (2.52%)  11
Neonatal demise   0/440 (0.00%)  0 0/436 (0.00%)  0 3/440 (0.68%)  3 3/436 (0.69%)  3
Indicates events were collected by systematic assessment
[1]
Neonatal ICU admission
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vitamin D Treatment (Mothers) Placebo (Mothers) Vitamin D Treatment (Offspring) Placebo (Offspring)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/440 (0.00%)      0/436 (0.00%)      0/440 (0.00%)      0/436 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott T. Weiss, MD, MS
Organization: Brigham and Women's Hospital
Phone: 617-525-2278
EMail: scott.weiss@channing.harvard.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Yu B, Zanetti KA, Temprosa M, Albanes D, Appel N, Barrera CB, Ben-Shlomo Y, Boerwinkle E, Casas JP, Clish C, Dale C, Dehghan A, Derkach A, Eliassen AH, Elliott P, Fahy E, Gieger C, Gunter MJ, Harada S, Harris T, Herr DR, Herrington D, Hirschhorn JN, Hoover E, Hsing AW, Johansson M, Kelly RS, Khoo CM, Kivimäki M, Kristal BS, Langenberg C, Lasky-Su J, Lawlor DA, Lotta LA, Mangino M, Le Marchand L, Mathé E, Matthews CE, Menni C, Mucci LA, Murphy R, Oresic M, Orwoll E, Ose J, Pereira AC, Playdon MC, Poston L, Price J, Qi Q, Rexrode K, Risch A, Sampson J, Seow WJ, Sesso HD, Shah SH, Shu XO, Smith GCS, Sovio U, Stevens VL, Stolzenberg-Solomon R, Takebayashi T, Tillin T, Travis R, Tzoulaki I, Ulrich CM, Vasan RS, Verma M, Wang Y, Wareham NJ, Wong A, Younes N, Zhao H, Zheng W, Moore SC. The Consortium of Metabolomics Studies (COMETS): Metabolomics in 47 Prospective Cohort Studies. Am J Epidemiol. 2019 Jun 1;188(6):991-1012. doi: 10.1093/aje/kwz028.
Layout table for additonal information
Responsible Party: Scott T. Weiss, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00920621    
Other Study ID Numbers: 655
5U01HL091528-03 ( U.S. NIH Grant/Contract )
HL091528-01A1
First Submitted: June 11, 2009
First Posted: June 15, 2009
Results First Submitted: February 28, 2017
Results First Posted: July 14, 2017
Last Update Posted: January 28, 2021