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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Scott T. Weiss, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00920621
First received: June 11, 2009
Last updated: August 5, 2013
Last verified: August 2013

June 11, 2009
August 5, 2013
September 2009
June 2014   (final data collection date for primary outcome measure)
Asthma or recurrent wheeze in the child. [ Time Frame: 1 year and 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00920621 on ClinicalTrials.gov Archive Site
  • (a) allergic sensitization (total and specific IgE), (b) eosinophil count, (c) doctor's diagnosis of eczema and (d) lower respiratory tract infections [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Children's levels of 25OHD [ Time Frame: 1 and 3 years ] [ Designated as safety issue: No ]
  • Preterm birth (birth <37 weeks gestation), preeclampsia, gestational hypertension, and/or Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP syndrome) [ Time Frame: Postpartum period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)

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

Asthma is one of the leading causes of morbidity in children with 60% of all cases diagnosed by age 3. Thus, finding factors that can lead to prevention of this disease would be of great public health importance. Vitamin D deficiency is highly prevalent among pregnant women, and thus, represents a potentially modifiable factor for the prevention of disease. Due to the effect of vitamin D in modulating immune responses, we believe that vitamin D deficiency in pregnant mothers leads to faulty immune system development in the neonate, predisposing them to asthma and allergy. We have observational data from two independent birth cohort studies that higher maternal intakes of vitamin D during pregnancy are each independently associated with a 50% reduction in risk for recurrent wheezing and asthma in 3- and 5-yr old children. However, in order to recommend this as a universal treatment to prevent asthma, a randomized, controlled, clinical trial is necessary. Therefore, we propose a two arm, double-blind, placebo controlled, randomized, clinical trial of Vitamin D, to determine whether higher vitamin D intake and levels in the pregnant mother will prevent asthma and allergy in the child at age 3. We will identify pregnant women who have asthma or allergies or whose partner has asthma or allergies, from obstetric clinics in the three clinical centers participating in this trial. We will recruit 870 pregnant women during the first trimester of pregnancy and randomize them to one of two treatment arms of a 4-year clinical trial: 4000 IU of Vitamin D in addition to usual prenatal vitamins, n=435; and usual prenatal vitamins alone, n=435. Our primary specific aim is to determine whether adequate vitamin D supplementation in the pregnant mother is associated with reduced incidence of asthma in the child during the first 3 years of life. The sub-aims of the study will include (1) To determine whether adequate vitamin D supplementation in the pregnant mother is associated with reduced secondary outcomes in the child of (a) allergic sensitization, (b) doctor's diagnosis of eczema and (c) lower respiratory tract infections during the first 3 years of life; and (2) To determine whether adequate vitamin D supplementation in the pregnant mother is associated with improved vitamin D status in the mothers and their offspring through measurement of 25(OH)D levels in maternal plasma, cord blood, and children's blood at 1 and 3 yrs of age and (3)To determine whether sufficient vitamin D supplementation in the pregnant mother is associated with reduced incidence of preterm birth (birth <37 weeks gestation), preeclampsia, gestational hypertension, and/or Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP syndrome) (PB/PE) compared to a usual care control group in VDAART.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Asthma
  • 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
  • Experimental: Vitamin D treatment
    vitamin D treatment plus prenatal multivitamins
    Interventions:
    • Dietary Supplement: Vitamin D 3 cholecalciferol
    • Dietary Supplement: Vitamin D3
  • Placebo Comparator: placebo
    placebo plus prenatal multivitamins
    Intervention: Dietary Supplement: Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
870
June 2014
June 2014   (final data collection date for primary outcome measure)

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)
Female
18 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00920621
655, 5U01HL091528-03, HL091528-01A1
Yes
Scott T. Weiss, Brigham and Women's Hospital
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Scott T Weiss Brigham and Women's Hospital
Brigham and Women's Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP