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Clinical Trials in Denmark / NCT00856947
Active, not recruiting Phase 1

Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood

NCT00856947 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen Studies on Asthma in Childhood
Phase
Phase 1
Started
2009-03
Last updated
2026-03-19

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

Cholecalciferol D3Placebo tablet

Cholecalciferol D3: 2 tablets of 1200 IU daily from week 24 of gestation to 1 week after delivery

Placebo tablet: 2 tablets containing no active substance

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Persistent wheeze — 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

Trial sites (2)

FacilityCityRegionStatus
Copenhagen University Hospital of Copenhagen Gentofte Municipality Gentofte
Næstved Hospital, Pediatric Department Næstved Næstved

More Copenhagen Studies on Asthma in Childhood trials in Denmark

Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms Recruiting
High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children Recruiting
Antibiotic Treatment of Recurrent Episodes of Asthma in Children Active, not recruiting
Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood Active, not recruiting
A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy Starting soon

Other trials for the same condition

THERMotherapy Against Persistent Bacterial LUNG Infections Starting soon
Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma Active, not recruiting
The Effect of Anti-IL17 on Airway Hyperresponsiveness and Resistance Recruiting
Mepolizumab to CRSwNP Through 12 Months - Randomised to FESS and Non-FESS Within the First 2 Weeks Active, not recruiting
Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00856947 on ClinicalTrials.gov ↗ ← All trials in Denmark