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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: June 18, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Recurrent wheeze [ Time Frame: 0 to 3 years of age ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 600
Study Start Date: March 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 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
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: June 18, 2012
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 May 23, 2013