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

C

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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