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Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood

Study acronym: ABCvitaminD
StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv18
  2. Minor Site details revised at 2 of 2 sitesv17
  3. Minor 4 versions Re-verified since Mar 8, 2022, no change to tracked fieldsv13-v16
  4. Notable Phase: Phase 2/3 to Phase 1
    • Primary and study completion dates: Apr 2019 to Jul 2027
    v12
  5. Minor Secondary endpoints: 11 to 12v11
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Secondary endpoints: 10 to 11v10
  2. Notable Primary and study completion dates: Apr 2017 to Apr 2019
    • Site details revised at 2 of 2 sites
    v9
  3. Notable Primary and study completion dates: Apr 2016 to Apr 2017v8
  4. Notable Primary and study completion dates: Apr 2014 to Apr 2016v7
  5. Notable Primary endpoint revised
    • Primary and study completion dates: Mar 2014 to Apr 2014
    • Secondary endpoints: 5 to 10
    v6
  6. Minor Re-verified, no change to tracked fieldsv5
  7. Minor Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints: 4 to 5
    • Site details revised at 2 of 2 sites
    v4
  8. Minor Re-verified, no change to tracked fieldsv3
  9. Minor Study sites revised (2)v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00856947
Lead Sponsor Copenhagen Studies on Asthma in Childhood
Conditions
(from sponsor)
Asthma
Related terms Asthma, Eczema, Hypersensitivity, Infections, Respiratory Sounds
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov