Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood (ABCvitaminD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier:
NCT00856947
First received: March 4, 2009
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

The aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by supplementation with high dose vitamin D to the mother during pregnancy. Participants are mothers and children of the ABC (Asthma Begins in Childhood) cohort. Mothers are recruited during pregnancy and receive daily supplement with 2400 IU of Vitamin D3 or placebo from week 24 og gestation to 1 week after delivery. In addition all mothers are advised to take the recommended dose of 400 IU vitamin D daily. The mothers in ABC also participate in an interventional trial with fish oil supplementation, and the vitamin D randomization is stratified by fish oil treatment group. The child is followed with acute and planned vits at the research unit, and wheeze is diagnosed according to predefined algorithms.


Condition Intervention Phase
Asthma
Dietary Supplement: Cholecalciferol D3
Other: Placebo tablet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood: An Interventional Trial in the ABC (Asthma Begins in Childhood) Cohort

Resource links provided by NLM:


Further study details as provided by Copenhagen Studies on Asthma in Childhood:

Primary Outcome Measures:
  • Persistent wheeze [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
    Age at onset of persistent wheeze diagnosed according to predefined algorithm of recurrent troublesome lung symptoms, response to treatment and relapse after withdrawal of treatment


Secondary Outcome Measures:
  • Infections [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]

    Main analysis:

    • Number of lower respiratory tract infections registered in daily diaries

    Secondary analyses:

    • Acute otitis media
    • Number of upper respiratory tract infections
    • Number of other infections
    • Total number of infections

  • Allergic sensitization [ Time Frame: 6 and 18 months of age ] [ Designated as safety issue: No ]
    Allergic sensitization at 6 and/or 18 months assessed by skin prick test and specific IgE in blood

  • Eczema [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
    Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria

  • Mothers levels of 25-OH-Vitamin D, PTH, Calcium, alkaline phosphatase [ Time Frame: 1 week after delivery ] [ Designated as safety issue: Yes ]
  • Growth [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
  • Asthma exacerbations [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
    Age at onset of severe asthma exacerbation diagnosed by predefined criteria of acute severe asthma requiring oral/high dose inhaled steroids or acute hospital contact

  • Neurological development [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]

    Main analysis:

    • Cognitive development assessed at 2½ years using the cognitive part of Bayley Scales of Infant and Toddler Development, third edition

    Secondary analyses:

    • Milestone development monitored prospectively by the parents using a registration form based on The Denver Development Index and WHO milestones registration (combined assessment by principal component analysis)
    • Language development assessed at 1 and 2 years of age with the Danish version of The MacArthur Bates Communicative Developmental Inventory (CDI)
    • The child´s general development (language, fine and gross motor, social and problem solving) at 3 years of age assessed with Ages and stages Questioner, third edition (ASQ-3)

  • Growth [ Time Frame: 0-3 years ] [ Designated as safety issue: No ]

    Main analysis:

    • Body composition (fat mass and bone mineral density) assessed by DEXA scan at 3 years of age

    Secondary analysis

    • Development of BMI from birth to 3 years assesses longitudinally in the research clinic


  • Systemic immune status [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    Main analysis Immune status at 18 months measured in stimulated whole blood as cytokine release (combined assessments by prinicipal component analyses)

    Secondary analyses Composition of immune cell subsets in whole blood at birth and at 18 months of age


  • Airway mucosal immune status [ Time Frame: 4 weeks and 2 years ] [ Designated as safety issue: No ]
    Immune status measured in airway mucosal lining fluid at 4 weeks and 2 years of age (combined assessments by prinicipal component analyses for each age point)


Estimated Enrollment: 600
Study Start Date: March 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
Dietary supplement: 2400 IU Vitamin D3 (2 tablets of 1200 IU) from week 24 of gestation to 1 week after delivery
Dietary Supplement: Cholecalciferol D3
2 tablets of 1200 IU daily from week 24 of gestation to 1 week after delivery
Other Name: Vitamin D from Camette, Denmark
Placebo Comparator: Placebo
Placebo: 2 placebo tablets with no active substance, identical to the active tablets, from week 24 of gestation to 1 week after delivery
Other: Placebo tablet
2 tablets containing no active substance
Other Name: Placebo tablets from Camette, Denmark

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Mother:

  • Pregnant in week 22-26 of gestation
  • Participating in the ABC-cohort
  • Living in Sealand, Denmark
  • Fluent in Danish
  • Willing to let the child participate in the study

Exclusion Criteria:

Mother:

  • Intake of more than 400 IU of vitamin D during the last 6 months
  • Endocrinological disease such as calcium metabolic disorder, parathyroid disorder, thyroid disorder or Diabetes type 1
  • Tuberculosis
  • Sarcoidosis
  • In need of diuretics or heart medication including calcium channel blockers
  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: NCT00856947

Locations
Denmark
Copenhagen University Hospital of Copenhagen
Gentofte, Denmark, 2820
Næstved Hospital, Pediatric Department
Næstved, Denmark, 4700
Sponsors and Collaborators
Copenhagen Studies on Asthma in Childhood
Investigators
Principal Investigator: Hans Bisgaard, MD, DMSc Copenhagen Studies on Asthma in Childhood
  More Information

No publications provided

Responsible Party: Copenhagen Studies on Asthma in Childhood
ClinicalTrials.gov Identifier: NCT00856947     History of Changes
Other Study ID Numbers: 2008-007871-26
Study First Received: March 4, 2009
Last Updated: February 25, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Copenhagen Studies on Asthma in Childhood:
wheeze
infections
allergy
eczema
vitamin D

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 26, 2014