This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART) (VDAART)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Scott T. Weiss, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00920621
First received: June 11, 2009
Last updated: July 12, 2017
Last verified: July 2017
Results First Received: February 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Prevention
Condition: Asthma
Interventions: Dietary Supplement: Vitamin D 3 cholecalciferol
Dietary Supplement: Vitamin D3

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vitamin D Treatment (Mothers) Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
Placebo (Mothers) 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).
Vitamin D Treatment (Offspring) Offspring of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
Placebo (Offspring) Offspring of mothers' assigned to placebo (daily placebo pill plus a multivitamin with 400 IU vitamin D). Serves as the "Control"

Participant Flow:   Overall Study
    Vitamin D Treatment (Mothers)   Placebo (Mothers)   Vitamin D Treatment (Offspring)   Placebo (Offspring)
STARTED   440   436   440   436 
COMPLETED   386   391   405   401 
NOT COMPLETED   54   45   35   35 
Lost to Follow-up                16                17                19                21 
Fetal/neonatal deaths                16                14                16                14 
Blood sample not collected                22                14                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vitamin D Treatment (Mothers) Mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D)
Placebo (Mothers) 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).
Vitamin D Treatment (Children) Children of mothers' assigned to vitamin D (daily 4,000 IU vitamin D plus a multivitamin with 400 IU vitamin D).
Placebo (Children) 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 Total of all reporting groups

Baseline Measures
   Vitamin D Treatment (Mothers)   Placebo (Mothers)   Vitamin D Treatment (Children)   Placebo (Children)   Total 
Overall Participants Analyzed 
[Units: Participants]
 440   436   405   401   1682 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.5  (5.5)   27.3  (5.6)   0  (0)   0  (0)   27.4  (5.6) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
         
Black   190   190   199   191   770 
White Hispanic   59   61   53   51   224 
White non-Hispanic   114   116   82   79   391 
Other   77   69   71   80   297 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Asthma or Recurrent Wheeze in First 3 Years of Life   [ Time Frame: First 3 years of life. ]

2.  Primary:   Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.   [ Time Frame: 32-38 weeks gestation ]

3.  Secondary:   Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.   [ Time Frame: 3 years ]

4.  Secondary:   Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.   [ Time Frame: 1 year visit ]

5.  Secondary:   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. ]

6.  Secondary:   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. ]

7.  Secondary:   Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.   [ Time Frame: Blood collection at childs' 3 year visit. ]

8.  Secondary:   Any Allergic Sensitization in the Child's First 3 Years of Life.   [ Time Frame: Child's first 3 years of life. ]

9.  Secondary:   Mass Spec Vitamin D Value From Cord Blood at Delivery   [ Time Frame: Blood collection at delivery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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:  
Name/Title: Scott T. Weiss, MD, MS
Organization: Brigham and Women's Hospital
phone: 617-525-2278
e-mail: scott.weiss@channing.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Scott T. Weiss, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00920621     History of Changes
Other Study ID Numbers: 655
5U01HL091528-03 ( U.S. NIH Grant/Contract )
HL091528-01A1
Study First Received: June 11, 2009
Results First Received: February 28, 2017
Last Updated: July 12, 2017