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: June 5, 2015
Last verified: June 2015
  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 2019
Estimated Primary Completion Date: June 2019 (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
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: June 5, 2015
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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 01, 2015