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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • Asthma or recurrent wheeze in the child. [ Time Frame: 1 year and 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • (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 ]

Estimated Enrollment: 870
Study Start Date: September 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders 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
Robert Strunk, MD
St. Louis, Missouri, United States
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Scott T Weiss Brigham and Women's Hospital
  More Information

No publications provided

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, HL091528-01A1
Study First Received: June 11, 2009
Last Updated: August 5, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by 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
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014