Overview

This trial is active, not recruiting.

Condition asthma
Treatments cholecalciferol d3, placebo tablet
Phase phase 2/phase 3
Sponsor Copenhagen Studies on Asthma in Childhood
Start date March 2009
End date April 2016
Trial size 600 participants
Trial identifier NCT00856947, 2008-007871-26

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Dietary supplement: 2400 IU Vitamin D3 (2 tablets of 1200 IU) from week 24 of gestation to 1 week after delivery
cholecalciferol d3 Vitamin D from Camette, Denmark
2 tablets of 1200 IU daily from week 24 of gestation to 1 week after delivery
(Placebo Comparator)
Placebo: 2 placebo tablets with no active substance, identical to the active tablets, from week 24 of gestation to 1 week after delivery
placebo tablet Placebo tablets from Camette, Denmark
2 tablets containing no active substance

Primary Outcomes

Measure
Persistent wheeze
time frame: 0 to 3 years of age

Secondary Outcomes

Measure
Infections
time frame: 0 to 3 years of age
Allergic sensitization
time frame: 6 and 18 months of age
Eczema
time frame: 0 to 3 years of age
Mothers levels of 25-OH-Vitamin D, PTH, Calcium, alkaline phosphatase
time frame: 1 week after delivery
Growth
time frame: 0 to 3 years of age
Asthma exacerbations
time frame: 0 to 3 years of age
Neurological development
time frame: 0-3 years
Growth
time frame: 0-3 years
Systemic immune status
time frame: 18 months
Airway mucosal immune status
time frame: 4 weeks and 2 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood: An Interventional Trial in the ABC (Asthma Begins in Childhood) Cohort
Principal investigator Hans Bisgaard, MD, DMSc
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Copenhagen Studies on Asthma in Childhood.