Actively Recruiting

Phase 3
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06570889

Vitamin D in Pregnancy for Prevention of Early Childhood Asthma (VICTORY)

Led by Professor Klaus Bønnelykke · Updated on 2025-09-30

2000

Participants Needed

1

Research Sites

334 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether taking higher doses of vitamin D during pregnancy can help prevent early childhood asthma or persistent wheezing in children up to 3 years old. The study targets pregnant women with higher levels of certain fatty acids in their blood. It also looks at other child health outcomes such as respiratory infections, eczema, allergies, bone fractures, development, mental health, and growth, following children until age 6 for some outcomes. Pregnant women are randomly assigned to take either a high dose of vitamin D (3200 IU daily) or a placebo capsule containing olive oil, starting between week 22 and 26 of pregnancy and continuing until one week after delivery. All participants also receive the recommended standard dose of 400 IU vitamin D. Blood samples will be collected for genetic and metabolic studies. The children will be followed for 3 years, with plans for extended follow-up until age 6 after the study is unblinded. Participants will be monitored through parent-reported symptoms, medical records, and registrations of medication use and hospital visits for their children. Researchers will assess lung and allergy symptoms, infections, developmental milestones, and mental health among other measures. The study includes regular data collection during the 3-year follow-up period and ongoing evaluation of health outcomes to better understand the impact of prenatal vitamin D supplementation on early childhood health.

CONDITIONS

Brief Title

VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant Danish women before week 26 with blood levels of EPA+DHA above 4.7% of total fatty acids
  • No current vitamin D intake above the recommended 400 IU/day
  • Female between 18 and 45 years old
Not Eligible

You will not qualify if you...

  • Endocrine, heart, kidney, or autoimmune disorders
  • Disorders requiring treatment with blood thinning medication
  • Current vitamin D intake above the recommended 400 IU/day

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit for blood screening test

Treatment

Duration - Approximately 16 weeks (from gestational week 22-26 until 1 week post-delivery)

Participants take vitamin D or placebo capsules daily from around week 22-26 of pregnancy until 1 week after delivery.

Daily capsule intake; visit schedule not specified

Long-term Monitoring

Duration - Up to 6 years

Participants' children are followed for health outcomes including asthma, infections, allergies, development, and growth until 6 years of age.

Longitudinal parent-reported symptom and health data collection; visit schedule not specified

Trial Site Locations

Total: 1 location

1

Copenhagen University Hospital of Copenhagen

Gentofte Municipality, Denmark, DK-2820

Actively Recruiting

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Research Team

K

Klaus Bønnelykke, PhD

U

Ulrik Ralfkiaer, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Fish oil and vitamin D in pregnancy for the prevention of early childhood asthma: study protocol for two double-blinded, randomised controlled trials.

Nicklas Brustad, Nilo Vahman, Ulrik Ralfkiaer...

https://pubmed.ncbi.nlm.nih.gov/39740942