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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
  Purpose
Vitamin D supplementation given to pregnant women will prevent asthma in their offspring and children.

Condition Intervention Phase
Asthma Dietary Supplement: Vitamin D 3 cholecalciferol Dietary Supplement: Vitamin D3 Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Scott T. Weiss, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 resperatory 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


Enrollment: 876
Study Start Date: September 2009
Estimated Study Completion Date: June 2019
Primary Completion Date: January 21, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • vitamin D
  • vitamin D3
  • cholecalciferol
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920621

Locations
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
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Scott T Weiss Brigham and Women's Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott T. Weiss, Principal Investigator, 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

Keywords provided by Scott T. Weiss, Brigham and Women's Hospital:
Asthma
Vitamin D
Randomized Control Trial

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 18, 2017