VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma (VICTORY)

Professor Klaus Bønnelykke

Status and phase: Enrolling; Phase 3

Conditions: Wheezing; Development, Child; Asthma; Psychiatric Diagnosis; Cognition Disorders in Children; Croup; Eczema; Gastrointestinal Infection; Respiratory Tract Infections; Allergy; Fractures, Bone

Treatments: Other: Olive oil; Dietary Supplement: Cholecalciferol D3

Study type: Interventional

Funder types: Other

Identifiers

NCT06570889

H-23055833-D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
• No disorders requiring treatment with blood thinning medication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,000 participants in 2 patient groups, including a placebo group

Vitamin D3 (cholecalciferol) 3200 IU/day

Experimental group

Description:

Oral intake of 1 capsule daily from week 22-26 of gestation until 1 week after delivery

Treatment:

Dietary Supplement: Cholecalciferol D3

Placebo Pearls with olive oil

Placebo Comparator group

Description:

Oral intake of 1 capsule daily from week 22-26 of gestation until 1 week after delivery

Treatment:

Other: Olive oil