Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood (ABCvitaminD)

Copenhagen Studies on Asthma in Childhood

Status and phase: Active, not recruiting; Phase 1

Conditions: Asthma

Treatments: Dietary Supplement: Cholecalciferol D3; Other: Placebo tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT00856947

2008-007871-26

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Vitamin D

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Cholecalciferol D3

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo tablet