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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00856947
Recruitment Status : Active, not recruiting
First Posted : March 6, 2009
Last Update Posted : February 6, 2019
Information provided by (Responsible Party):
Copenhagen Studies on Asthma in Childhood

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Dietary Supplement: Cholecalciferol D3 Other: Placebo tablet Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2009
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Persistent wheeze [ Time Frame: 0 to 3 years of age ]
    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 :
  1. Infections [ Time Frame: 0 to 3 years of age ]

    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

  2. Allergic sensitization [ Time Frame: 6 and 18 months of age ]
    Allergic sensitization at 6 and/or 18 months assessed by skin prick test and specific IgE in blood

  3. Eczema [ Time Frame: 0 to 3 years of age ]
    Age at onset of eczema diagnosed prospectively by research doctors according to predefined algorithm based upon Hanifin and Rajka criteria

  4. Mothers levels of 25-OH-Vitamin D, PTH, Calcium, alkaline phosphatase [ Time Frame: 1 week after delivery ]
  5. Growth [ Time Frame: 0 to 3 years of age ]
  6. Asthma exacerbations [ Time Frame: 0 to 3 years of age ]
    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

  7. Neurological development [ Time Frame: 0-3 years ]

    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)

  8. Growth [ Time Frame: 0-3 years ]

    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

  9. Systemic immune status [ Time Frame: 18 months ]

    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

  10. Airway mucosal immune status [ Time Frame: 4 weeks and 2 years ]
    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)

  11. 17q21 genotype and sphingolipid metabolites [ Time Frame: 6 months ]
    In a secondary analyses, we will determine the effect of 17q21 genotype on the efficacy of vitamin D supplementation in the prevention of asthma/wheeze. We will compute hazard ratios for the reduction in asthma/wheeze risk associated with prenatal supplementation, stratified by rs12936231. rs12936231 is a functional SNP influencing expression of ORMDL3, and given the role of ORMDL3 as a key sphingolipid biosynthesis regulator, we will subsequently investigate the relative abundance of sphingolipids between those in the vitamin D Intervention arm and those in the placebo group, stratified by 17q21 genotype. Finally we will identify interactions between prenatal vitamin D supplementation, rs12936231 genotype and sphingolipid metabolism in the risk of asthma/wheeze by age three.

  12. Dental health [ Time Frame: 6 year ]
    Caries and enamel defects (molar incisor hypomineralization, MIH) determined at a dental examination at age 6 years.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:


  • 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:


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00856947

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Copenhagen Studies on Asthma in Childhood Identifier: NCT00856947     History of Changes
Other Study ID Numbers: 2008-007871-26
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

Keywords provided by Copenhagen Studies on Asthma in Childhood:
vitamin D

Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents