AsthmaPhase 3VICTORYNCT06570889
VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma
A Phase 3 study testing Cholecalciferol D3 and Olive oil in people with Asthma and Respiratory Tract Infections, run by Professor Klaus Bønnelykke at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma, Respiratory Tract Infections, Gastrointestinal Infection
- What is being tested?
- Cholecalciferol D3 and Olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Dec 2024to Mar 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
- 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
- No disorders requiring treatment with blood thinning medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital of Copenhagen
Gentofte Municipality, DK-2820
Klaus Bønnelykke, PhD, +4538677360, kb@copsac.com
Ulrik Ralfkiaer, PhD, +4538674164, ulrik.ralfkiaer@dbac.dk
About this study
Official title: VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma (VICTORY)
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.
Read the 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.
- Conditions
- Asthma, Respiratory Tract Infections, Gastrointestinal Infection, Croup, Eczema, Allergy
- Being tested
- Cholecalciferol D3, Olive oil
- Keywords
- Childhood, Asthma, Infections, Eczema, Allergy, Development, Psychiatry, Bone development, Cognition, Growth
- Medical subject headings
- Asthma, Respiratory Tract Infections, Croup, Eczema, Hypersensitivity, Respiratory Sounds, Fractures, Bone, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol D3Dietary supplement
Also called D-Pearls, PharmaNord, DK
Oral intake of 1 capsule per day from week 22-26 in pregnancy to 1 week after delivery
Olive oilOther
Also called Placebo Pearls, PharmaNord, DK
Oral intake of 1 capsule per day from week 22-26 in pregnancy to 1 week after delivery
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 (cholecalciferol) 3200 IU/day | Experimental | Oral intake of 1 capsule daily from week 22-26 of gestation until 1 week after delivery Receives: Dietary Supplement: Cholecalciferol D3 |
| Placebo Pearls with olive oil | Placebo comparator | Oral intake of 1 capsule daily from week 22-26 of gestation until 1 week after delivery Receives: Other: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (48)
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.
Measured: 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.
Measured: 3 years
Wheeze episodes age 0-3 years
Parental reports of wheezing. Outcome analyses: total no. of episodes with wheeze age 0-3 years.
Measured: 3 years
Inhaled bronchodilator use from parental reports age 0-3 years
Outcome analyses: total no. of days with bronchodilator use age 0-3.
Measured: 3 years
Inhaled bronchodilator prescriptions from medical record checks age 0-3 years
Outcome analyses: total no. of prescriptions age 0-3.
Measured: 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.
Measured: 3 years
Asthma controller medication prescriptions from medical record checks age 0-3 years
Outcome analyses: total no. of prescriptions age 0-3.
Measured: 3 years
Asthma hospitalizations or emergency department visits age 0-3 years
Outcome analyses: total no. of episodes age 0-3 years.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Fever episodes age 0-3 years
Based on parental reports.
Outcome analyses: total no. of episodes with symptoms age 0-3 years.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Strength and difficulties at age 3 years
From the Strengths and Difficulties Questionnaire (SDQ), which is a brief behavioral screening questionnaire.
Emotional symptoms: range 0-10, a low score means better outcome. Behavioral symptoms: range 0-10, a low score means better outcome. Hyperactivity/attention difficulties:range 0-10, a low score means better outcome.
Problems with children of the same age:range 0-10, a low score means better outcome.
Social strengths:range 0-10, a high score means better outcome. Impact on well-being and functioning: range 0-10, a low score means better outcome.
Outcome analyses: SDQ scores at age 3 years.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 years
Strength and difficulties at age 6 years
From the Strengths and Difficulties Questionnaire (SDQ), which is a brief behavioral screening questionnaire.
Emotional symptoms: range 0-10, a low score means better outcome. Behavioral symptoms: range 0-10, a low score means better outcome. Hyperactivity/attention difficulties:range 0-10, a low score means better outcome.
Problems with children of the same age:range 0-10, a low score means better outcome.
Social strengths:range 0-10, a high score means better outcome. Impact on well-being and functioning: range 0-10, a low score means better outcome.
Outcome analyses: SDQ scores at age 6 years.
Measured: 6 years
ADHD symptoms at age 6 years
From the ADHD rating scale-IV preschool, a dimensional questionnaire for ADHD symptoms in preschool children.
For attention symptoms: range: 0-27, a low score means better outcome. For impulsivity-hyperactivity: range: 0-27, a low score means better outcome. For behavioral problems: range: 0-24, a low score means better outcome.
Outcome analyses: ADHD symptom scores at age 6 years.
Measured: 6 years
Psychopathology screening at age 6 years
From the Child Behavior Check List; a questionnaire for general screening of preschool psychopathology.
Total problem score: range 0-236, a low score means better outcome Internalizing problems score: range 0-64, a low score means better outcome Externalizing problems score: range 0-70, a low score means better outcome
Outcome analyses: Total syndrome scales at age 6 years.
Measured: 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.
Measured: 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.
Measured: 6 years
ADHD symptoms at age 3 years
From the ADHD rating scale-IV preschool, a dimensional questionnaire for ADHD symptoms in preschool children.
For inattentive score: range: 0-27, a low score means better outcome. For impulsivity-hyperactivity: range: 0-27, a low score means better outcome.
Outcome analyses: ADHD symptom scores at age 3 years.
Measured: 3 years
Social behavior assessment at age 3 years
From the Social Responsiveness Scale, Second Edition; a questionnaire for screening for autistic traits:
Total score range: 0-195, a low score indicates better outcome.
Outcome analyses: Total problem scores at age 3 years.
Measured: 3 years
Social behavior assessment at age 6 years
From the Social Responsiveness Scale, Second Edition; a questionnaire for screening for autistic traits.
Total score range: 0-195, low score indicates a better outcome.
Outcome analyses: Total problem scores at age 6 years.
Measured: 6 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.
Total problem score: range 0-198, a low score means better outcome
Outcome analyses: Total syndrome scales at age 3 years.
Measured: 3 years
Adaptive behavior at 3 years
Adaptive Behavior Assessment System, Third Edition (ABAS-3)is used to assess everyday, adaptive functioning.
Total score range: 0-645, a low score indicate poorer outcome.
Measured: 3 years
Adaptive behavior at 6 years
Adaptive Behavior Assessment System, Third Edition (ABAS-3)is used to assess everyday, adaptive functioning.
Total score range: 0-633, a low score indicate poorer outcome.
Measured: 6 years
Cognitive assessment age 0-3 years
From Behavior Rating Inventory of Executive Function in preschool children; a measurement of executive functions.
Total problem score: range 63-189, a low score means better outcome.
Outcome analyses: Index values at age 3 years.
Measured: 3 years
Cognitive assessment age 0-6 years
From Behavior Rating Inventory of Executive Function in preschool children; a measurement of executive functions.
Total problem score: range 60-180, a low score means better outcome.
Outcome analyses: Index values at age 6 years.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start20 Dec 2024
- Primary completionOct 2026 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Klaus Bønnelykke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Klaus Bønnelykke, Copenhagen Studies on Asthma in Childhood
- Investigators
- Klaus Bønnelykke, PhD, Principal investigator, Copenhagen Studies on Asthma in ChildhoodBo Chawes, PhD, Principal investigator, Copenhagen Studies on Asthma in Childhood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570889
- Sponsor's protocol ID
- H-23055833-D
- Acronym
- VICTORY
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brustad N, Vahman N, Ralfkiaer U, Mikkelsen M, Brandt S, Kyvsgaard JN, Vinding R, Stokholm J, Chawes B, Bonnelykke K. Fish oil and vitamin D in pregnancy for the prevention of early childhood asthma: study protocol for two double-blinded, randomised controlled trials. BMJ Open. 2024 Dec 31;14(12):e092902. doi: 10.1136/bmjopen-2024-092902.
PubMed 39740942
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma (VICTORY)
- ClinicalTrials.gov ID
- NCT06570889
- Acronym / sponsor ID
- VICTORY / H-23055833-D
- Conditions
- Asthma, Respiratory Tract Infections, Gastrointestinal Infection, Croup, Eczema, Allergy
- Keywords
- Childhood, Asthma, Infections, Eczema, Allergy, Development, Psychiatry, Bone development
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Professor Klaus BønnelykkeUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 (cholecalciferol) 3200 IU/day | Experimental | Dietary Supplement: Cholecalciferol D3Oral intake of 1 capsule daily from week 22-26 of gestation until 1 week after delivery |
| Placebo Pearls with olive oil | Placebo comparator | Other: Olive oilOral intake of 1 capsule daily from week 22-26 of gestation until 1 week after delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol D3Also: D-Pearls, PharmaNord, DKOral intake of 1 capsule per day from week 22-26 in pregnancy to 1 week after delivery | Dietary supplement | Vitamin D3 (cholecalciferol) 3200 IU/day |
| Olive oilAlso: Placebo Pearls, PharmaNord, DKOral intake of 1 capsule per day from week 22-26 in pregnancy to 1 week after delivery | Other | Placebo Pearls with olive oil |
Primary outcome
Early childhood asthma/persistent wheeze age 0-3 years
Time frame: 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.
48 secondary outcomes
Atopic/non-atopic wheeze or asthma age 0-3 years
Time frame: 3 years
Troublesome lung symptoms age 0-3 years
Time frame: 3 years
Wheeze episodes age 0-3 years
Time frame: 3 years
Inhaled bronchodilator use from parental reports age 0-3 years
Time frame: 3 years
Inhaled bronchodilator prescriptions from medical record checks age 0-3 years
Time frame: 3 years
Asthma controller medication use from parental reports age 0-3 years
Time frame: 3 years
Asthma controller medication prescriptions from medical record checks age 0-3 years
Time frame: 3 years
Asthma hospitalizations or emergency department visits age 0-3 years
Time frame: 3 years
Eczema age 0-3 years
Time frame: 3 years
Allergic rhinitis age 0-3 years
Time frame: 3 years
Food allergy 0-3 years
Time frame: 3 years
Lower respiratory tract infections age 0-3 years
Time frame: 3 years
Gastrointestinal infections age 0-3 years
Time frame: 3 years
Croup age 0-3 years
Time frame: 3 years
Fever episodes age 0-3 years
Time frame: 3 years
Absences from daycare age 0-3 years
Time frame: 3 years
Bone fractures age 0-3 years
Time frame: 3 years
Developmental milestones age 0-3 years
Time frame: 3 years
Strength and difficulties at age 3 years
Time frame: 3 years
BMI age 0-3 years
Time frame: 3 years
Waist circumference age 0-3 years
Time frame: 3 years
Persistent wheeze or asthma age 0-6 years
Time frame: 6 years
Current asthma at age 6 years
Time frame: 6 years
Asthma or wheeze yearly prevalence 0-6 years
Time frame: 6 years
Atopic/non-atopic asthma at age 6 years
Time frame: 6 years
Asthma controller medication 0-6 years
Time frame: 6 years
Inhaled bronchodilators age 0-6 years
Time frame: 6 years
Asthma hospitalizations or emergency department visits age 0-6 years
Time frame: 6 years
Eczema age 0-6 years
Time frame: 6 years
Allergic rhinitis age 0-6 years
Time frame: 6 years
Food allergy age 0-6 years
Time frame: 6 years
Lower respiratory tract infections age 0-6 years
Time frame: 6 years
Gastrointestinal infections age 0-6 years
Time frame: 6 years
Croup age 0-6 years
Time frame: 6 years
Bone fractures age 0-6 years
Time frame: 6 years
Strength and difficulties at age 6 years
Time frame: 6 years
ADHD symptoms at age 6 years
Time frame: 6 years
Psychopathology screening at age 6 years
Time frame: 6 years
BMI age 0-6 years
Time frame: 6 years
Waist circumference age 0-6 years
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 39740942Brustad N, Vahman N, Ralfkiaer U, Mikkelsen M, Brandt S, Kyvsgaard JN, Vinding R, Stokholm J, Chawes B, Bonnelykke K. Fish oil and vitamin D in pregnancy for the prevention of early childhood asthma: study protocol for two double-blinded, randomised controlled trials. BMJ Open. 2024 Dec 31;14(12):e092902. doi: 10.1136/bmjopen-2024-092902.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klaus Bønnelykke, PhD principal investigator
Copenhagen Studies on Asthma in Childhood
Bo Chawes, PhD principal investigator
Copenhagen Studies on Asthma in Childhood
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cholecalciferol D3 and Olive oil in people with Asthma and Respiratory Tract Infections, run by Professor Klaus Bønnelykke at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klaus Bønnelykke, PhD (+4538677360, kb@copsac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early childhood asthma/persistent wheeze age 0-3 years (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06570889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.