Clinical trial NCT06570889: VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma
Official title: VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma (VICTORY)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Asthma
Respiratory Tract Infections
Gastrointestinal Infection
Croup
Eczema
Allergy
Wheezing
Fractures, Bone
Development, Child
Cognition Disorders in Children
Psychiatric Diagnosis
Keywords: Childhood
Asthma
Infections
Eczema
Allergy
Development
Psychiatry
Bone development
Cognition
Growth
Lead sponsor: Copenhagen Studies on Asthma in Childhood
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.

Detailed description: Randomization of 2000 pregnant women to vitamin D of high-dose (3200 IU/day) vitamin D vs placebo on top of the recommended 400 IU/day. Supplementation begins in gestational week 24 (22-26) until 1 week after delivery. Allocation to the trial will be determined based on the pre-interventional maternal blood levels of EPA+DHA with a dried blood screening test. Women with high levels (above 4.7% of total fatty acids) will be assigned to the vitamin D RCT. Maternal blood will be used for genetic, metabolomic and proteomic profiling. A 3-year follow-up of the children with longitudinal registration of parent reported symptoms, diagnoses, medication use, and hospitalizations will be performed. The primary outcome is persistent wheeze or asthma until age 3 years, with predefined analyses of effect modification by maternal genotypes. Secondary outcomes are lower respiratory tract infections, gastrointestinal infections, croup, troublesome lung symptoms, eczema, allergy, bone fractures, developmental milestones, mental health, cognition, and growth until age 3 years. A follow-up on both primary and secondary outcomes is planned after unblinding, from age 3 to 6 years.

Eligibility criteria: * 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
* No endocrine-, heart-, kidney- or auto-immune disorders

Primary outcomes:
measure: Early childhood asthma/persistent wheeze age 0-3 years
timeFrame: 3 years
Secondary outcomes:
measure: Atopic/non-atopic wheeze or asthma age 0-3 years
timeFrame: 3 years
measure: Troublesome lung symptoms age 0-3 years
timeFrame: 3 years
measure: Wheeze episodes age 0-3 years
timeFrame: 3 years
measure: Inhaled bronchodilator use from parental reports age 0-3 years
timeFrame: 3 years
measure: Inhaled bronchodilator prescriptions from medical record checks age 0-3 years
timeFrame: 3 years
measure: Asthma controller medication use from parental reports age 0-3 years
timeFrame: 3 years
measure: Asthma controller medication prescriptions from medical record checks age 0-3 years
timeFrame: 3 years
measure: Asthma hospitalizations or emergency department visits age 0-3 years
timeFrame: 3 years
measure: Eczema age 0-3 years
timeFrame: 3 years
measure: Allergic rhinitis age 0-3 years
timeFrame: 3 years
measure: Food allergy 0-3 years
timeFrame: 3 years
measure: Lower respiratory tract infections age 0-3 years
timeFrame: 3 years
measure: Gastrointestinal infections age 0-3 years
timeFrame: 3 years
measure: Croup age 0-3 years
timeFrame: 3 years
measure: Fever episodes age 0-3 years
timeFrame: 3 years
measure: Absences from daycare age 0-3 years
timeFrame: 3 years
measure: Bone fractures age 0-3 years
timeFrame: 3 years
measure: Developmental milestones age 0-3 years
timeFrame: 3 years
measure: Strength and difficulties at age 3 years
timeFrame: 3 years
measure: BMI age 0-3 years
timeFrame: 3 years
measure: Waist circumference age 0-3 years
timeFrame: 3 years
measure: Persistent wheeze or asthma age 0-6 years
timeFrame: 6 years
measure: Current asthma at age 6 years
timeFrame: 6 years
measure: Asthma or wheeze yearly prevalence 0-6 years
timeFrame: 6 years
measure: Atopic/non-atopic asthma at age 6 years
timeFrame: 6 years
measure: Asthma controller medication 0-6 years
timeFrame: 6 years
measure: Inhaled bronchodilators age 0-6 years
timeFrame: 6 years
measure: Asthma hospitalizations or emergency department visits age 0-6 years
timeFrame: 6 years
measure: Eczema age 0-6 years
timeFrame: 6 years
measure: Allergic rhinitis age 0-6 years
timeFrame: 6 years
measure: Food allergy age 0-6 years
timeFrame: 6 years
measure: Lower respiratory tract infections age 0-6 years
timeFrame: 6 years
measure: Gastrointestinal infections age 0-6 years
timeFrame: 6 years
measure: Croup age 0-6 years
timeFrame: 6 years
measure: Bone fractures age 0-6 years
timeFrame: 6 years
measure: Strength and difficulties at age 6 years
timeFrame: 6 years
measure: ADHD symptoms at age 6 years
timeFrame: 6 years
measure: Psychopathology screening at age 6 years
timeFrame: 6 years
measure: BMI age 0-6 years
timeFrame: 6 years
measure: Waist circumference age 0-6 years
timeFrame: 6 years
measure: ADHD symptoms at age 3 years
timeFrame: 3 years
measure: Social behavior assessment at age 3 years
timeFrame: 3 years
measure: Social behavior assessment at age 6 years
timeFrame: 6 years
measure: Psychopathology screening at age 3 years
timeFrame: 3 years
measure: Adaptive behavior at 3 years
timeFrame: 3 years
measure: Adaptive behavior at 6 years
timeFrame: 6 years
measure: Cognitive assessment age 0-3 years
timeFrame: 3 years
measure: Cognitive assessment age 0-6 years
timeFrame: 6 years
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Copenhagen University Hospital of Copenhagen
Study officials:
affiliation: Copenhagen Studies on Asthma in Childhood
name: Klaus Bønnelykke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen Studies on Asthma in Childhood
name: Bo Chawes, PhD
role: PRINCIPAL_INVESTIGATOR
References: