VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma
NCT Number: NCT06570889
Acronym: VICTORY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Asthma|Respiratory Tract Infections|Gastrointestinal Infection|Croup|Eczema|Allergy|Wheezing|Fractures, Bone|Development, Child|Cognition Disorders in Children|Psychiatric Diagnosis
Interventions: DIETARY_SUPPLEMENT: Cholecalciferol D3|OTHER: Olive oil
Sponsor: Professor Klaus Bønnelykke
Sex: FEMALE
Age: ADULT
Enrollment: 2000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-11
Completion Date: 2033-03
Locations: Copenhagen University Hospital of Copenhagen, Gentofte, DK-2820, Denmark

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.

Primary Outcome Measures: Early childhood asthma/persistent wheeze age 0-3 years, Defined as either a) parental report of a minimum of 2 wheeze episodes with at least 1 after the child's second birthday and redemption of at least 2 prescriptions of asthma controller medication with at least 1 being after the child's second birthday or b) a minimum of 2 ED visits or hospitalizations due to asthmatic symptoms, and at least 1 of these being after the child's second birthday or c) parental report of physician-diagnosed asthma age 0-3 years

Outcome analysis: risk (survival analysis) of persistent wheeze or asthma at age 0-3 years., 3 years
Secondary Outcome Measures: Atopic/non-atopic wheeze or asthma age 0-3 years, Parental reports of physician diagnosed asthma in combination with eczema and/or allergic rhinitis.

Outcome analyses: asthma/persistent wheeze with/without eczema and/or allergic rhinitis (yes/no) by age 3 years. Each subtype is compared with children without asthma., 3 years|Troublesome lung symptoms age 0-3 years, Defined as cough, wheeze or dyspnea severely affecting the well-being of the child for at least 3 consecutive days based on parental reports.

Outcome analyses: total no. of episodes with symptoms age 0-3 years., 3 years|Wheeze episodes age 0-3 years, Parental reports of wheezing. Outcome analyses: total no. of episodes with wheeze age 0-3 years., 3 years|Inhaled bronchodilator use from parental reports age 0-3 years, Outcome analyses: total no. of days with bronchodilator use age 0-3., 3 years|Inhaled bronchodilator prescriptions from medical record checks age 0-3 years, Outcome analyses: total no. of prescriptions age 0-3., 3 years|Asthma controller medication use from parental reports age 0-3 years, Outcome analyses: total no. of days with use of asthma controller medication age 0-3., 3 years|Asthma controller medication prescriptions from medical record checks age 0-3 years, Outcome analyses: total no. of prescriptions age 0-3., 3 years|Asthma hospitalizations or emergency department visits age 0-3 years, Outcome analyses: total no. of episodes age 0-3 years., 3 years|Eczema age 0-3 years, Parental reports of physician-diagnosed eczema and prescribed topical antiinflammatory medication on medical record checks.

Outcome analyses: risk (survival analysis) of any eczema age 0-3 years and current eczema (yes/no) by age 3 years., 3 years|Allergic rhinitis age 0-3 years, Based on parental reports of physician-diagnosed allergic rhinitis.

Outcome analyses: allergic rhinitis (yes/no) by age 3 years., 3 years|Food allergy 0-3 years, Parental reports of physician-diagnosed food allergy.

Outcome analyses: any food allergy (yes/no) by age 3 years., 3 years|Lower respiratory tract infections age 0-3 years, Parental reports of physician-diagnosed bronchiolitis or pneumonia.

Outcome analysis: risk (survival analysis) of first lower respiratory tract infection and total no. of lower respiratory tract infections age 0-3 years., 3 years|Gastrointestinal infections age 0-3 years, Parental reports.

Outcome analyses: risk (survival analysis) of any gastroenteritis episode and total no. of gastroenteritis episodes age 0-3 years., 3 years|Croup age 0-3 years, Parental reports of physician diagnosed croup.

Outcome analysis: risk (survival analysis) of any croup episode and total no. of croup episodes age 0-3 years., 3 years|Fever episodes age 0-3 years, Based on parental reports.

Outcome analyses: total no. of episodes with symptoms age 0-3 years., 3 years|Absences from daycare age 0-3 years, Due to illnesses based on parental reports.

Outcome analyses: total no. of absence days age 0-3 years., 3 years|Bone fractures age 0-3 years, Assessed by medical record checks including all radiologically verified fractures of larger long bones (i.e. clavicle, radius, ulna, tibia, fibula, femur and humerus).

Outcome analyses: total no. of fractures age 0-3 years., 3 years|Developmental milestones age 0-3 years, Monitored every 6 months until age 3 years by the parents using a registration form based on The Denver Development Index and WHO milestones registration.

Outcome analyses: combined assessment of age at achievement across milestones by principal component analysis., 3 years|Strength and difficulties at age 3 years, From the Strengths and Difficulties Questionnaire (SDQ), which is a brief behavioral screening questionnaire.

Outcome analyses: SDQ scores at age 3 years., 3 years|ADHD symptoms at age 3 years, From the ADHD rating scale-IV preschool, a dimensional questionnaire for ADHD symptoms in preschool children.

Outcome analyses: ADHD symptom scores at age 3 years., 3 years|Social behavior assessment at age 3 years, From the Social Responsiveness Scale, Second Edition; a questionnaire for screening for autistic traits:

Outcome analyses: Total problem scores at age 3 years., 3 years|Psychopathology screening at age 3 years, From the Child Behavior Check List 1,5-5 years; a questionnaire for general screening of preschool psychopathology.

Outcome analyses: Total syndrome scales at age 3 years., 3 years|Cognitive assessment age 0-3 years, From Behavior Rating Inventory of Executive Function in preschool children; a measurement of executive functions.

Outcome analyses: Index values at age 3 years., 3 years|BMI age 0-3 years, From parental reports every 6 months.

Outcome analyses: development of BMI age 0-3 years and current BMI at age 3., 3 years|Waist circumference age 0-3 years, From parental reports every 6 months.

Outcome analyses: development of waist circumference age 0-3 years and current waist circumference at age 3., 3 years|Persistent wheeze or asthma age 0-6 years, Defined similarly to the primary outcome

Outcome analysis: risk (survival analysis) of persistent wheeze or asthma at age 0-6 years, 6 years|Current asthma at age 6 years, Defined similarly to the primary outcome and with symptoms and/or asthma medication use in the last 12 months at age 6.

Outcome analyses: Current wheeze or asthma (yes/no) by age 6 years., 6 years|Asthma or wheeze yearly prevalence 0-6 years, Defined as in the primary outcome and current disease defined from parental reports of wheeze and/or asthma medication use.

Outcome analyses: Yearly prevalence of wheeze or asthma medication use (yes/no) 0-6 years., 6 years|Atopic/non-atopic asthma at age 6 years, Parental reports of physician diagnosed asthma in combination with eczema and/or allergic rhinitis.

Outcome analyses: Current asthma with/without eczema and/or allergic rhinitis (yes/no) by age 6 years. Each subtype is compared with children without asthma., 6 years|Asthma controller medication 0-6 years, From redeemed medication prescriptions (inhaled corticosteroids and leukotriene modifiers) based on medical record checks:

Outcome analyses: total no. of prescriptions age 0-6 years., 6 years|Inhaled bronchodilators age 0-6 years, From redeemed inhaled bronchodilators based on medical record checks.

Outcome analyses: total no. of prescriptions age 0-6 years., 6 years|Asthma hospitalizations or emergency department visits age 0-6 years, Based on medical record checks.

Outcome analyses: total no. of episodes age 0-6 years., 6 years|Eczema age 0-6 years, Based on parental reports of physician diagnosed eczema.

Outcome analyses: risk (survival analysis) of any eczema age 0-6 years and current eczema (yes/no) by age 6 years., 6 years|Allergic rhinitis age 0-6 years, Based on parental reports of physician-diagnosed allergic rhinitis and on medical record checks.

Outcome analyses: allergic rhinitis (yes/no) by age 6 years., 6 years|Food allergy age 0-6 years, Based on parental reports of physician-diagnosed food allergy.

Outcome analyses: any food allergy (yes/no) by age 6 years., 6 years|Lower respiratory tract infections age 0-6 years, Based on parental reports of physician-diagnosed bronchiolitis or pneumonia.

Outcome analysis: risk (survival analysis) of first lower respiratory tract infection and total no. of lower respiratory tract infections age 0-6 years., 6 years|Gastrointestinal infections age 0-6 years, Based on parental reports.

Outcome analyses: risk (survival analysis) of any gastroenteritis episode and total no. of gastroenteritis episodes age 0-6 years., 6 years|Croup age 0-6 years, Based on parental reports of physician diagnosed croup.

Outcome analysis: risk (survival analysis) of any croup episode and total no. of croup episodes age 0-6 years., 6 years|Bone fractures age 0-6 years, Assessed by medical record checks including all radiologically verified fractures of larger long bones (i.e. clavicle, radius, ulna, tibia, fibula, femur and humerus).

Outcome analyses: total no. of fractures age 0-6 years., 6 years|Strength and difficulties at age 6 years, From the Strengths and Difficulties Questionnaire (SDQ), which is a brief behavioral screening questionnaire.

Outcome analyses: SDQ scores at age 6 years., 6 years|ADHD symptoms at age 6 years, From the ADHD rating scale-IV preschool, a dimensional questionnaire for ADHD symptoms in preschool children.

Outcome analyses: ADHD symptom scores at age 6 years., 6 years|Social behavior assessment at age 6 years, From the Social Responsiveness Scale, Second Edition; a questionnaire for screening for autistic traits.

Outcome analyses: Total problem scores at age 6 years., 6 years|Psychopathology screening at age 6 years, From the Child Behavior Check List; a questionnaire for general screening of preschool psychopathology.

Outcome analyses: Total syndrome scales at age 6 years., 6 years|Cognitive assessment age 0-6 years, From Behavior Rating Inventory of Executive Function in preschool children; a measurement of executive functions.

Outcome analyses: Index values at age 6 years., 6 years|BMI age 0-6 years, From parental reports every 6 months.

Outcome analyses: development of BMI age 0-6 years and current BMI at age 6., 6 years|Waist circumference age 0-6 years, From parental reports every 6 months.

Outcome analyses: development of waist circumference age 0-6 years and current waist circumference at age 6., 6 years