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

March 4, 2009
February 25, 2014
March 2009
April 2014   (final data collection date for primary outcome measure)
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
Recurrent wheeze [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00856947 on ClinicalTrials.gov Archive Site
  • 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)
  • Infections (upper respiratory / lower respiratory) [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
  • Allergy [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
  • Eczema [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]
  • Mothers levels of 25-OH-Vitamin D, PTH, Calcium, alkaline phosphatase [ Time Frame: 1 week after delivery ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood
Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood: An Interventional Trial in the ABC (Asthma Begins in Childhood) Cohort

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Asthma
  • 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
  • Other: Placebo tablet
    2 tablets containing no active substance
    Other Name: Placebo tablets from Camette, Denmark
  • 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
    Intervention: Dietary Supplement: Cholecalciferol D3
  • 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
    Intervention: Other: Placebo tablet
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
600
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00856947
2008-007871-26
Yes
Copenhagen Studies on Asthma in Childhood
Copenhagen Studies on Asthma in Childhood
Not Provided
Principal Investigator: Hans Bisgaard, MD, DMSc Copenhagen Studies on Asthma in Childhood
Copenhagen Studies on Asthma in Childhood
February 2014

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