Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

Dietary supplement: 2400 IU Vitamin D3 (2 tablets of 1200 IU) from week 24 of gestation to 1 week after delivery

Group Type ACTIVE_COMPARATOR

Cholecalciferol D3

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo: 2 placebo tablets with no active substance, identical to the active tablets, from week 24 of gestation to 1 week after delivery

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type OTHER

2 tablets containing no active substance

Interventions

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Cholecalciferol D3

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

Intervention Type DIETARY_SUPPLEMENT

Placebo tablet

2 tablets containing no active substance

Intervention Type OTHER

Other Intervention Names

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Vitamin D from Camette, Denmark Placebo tablets from Camette, Denmark

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes