Vitamin D and atopic allergy

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000359-16-SE

Enrollment

800

Registered

2006-06-16

Start date

2007-04-16

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cumulative incidence of atopic allergy specified as atopic dermatitis, allergic asthma, and allergic rhinitis. Since IMP is a food supplement to protect from rickets we are looking at clinical symptoms of vitamin D deficiency as well and measure serum levels of calcidiol.

Interventions

Product Name: Placebo Pharmaceutical Form: Oral drops, solution Trade Name: AD-vitamin Olja Product Name: AD-Vitamin Olja Pharmaceutical Form: Oral drops, solution INN or Proposed INN: RETINOL CAS Nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Any term and healthy infant of both sexes with parents who are willing to participate in the study and will sign the informed consent formula and who are able to communicate with the study personel without interpretor. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any premature or otherwise incapacitated infant or infant with parents not signing the informed consent formula or with parents who need an interpretor. Furthermore a skin type IV-VI, with dark skin pigmentation with impact on endogenous vitamin D synthesis. Any infant from a family where ethnic or traditional factors will result in a diet which differs from the feeding program recommended by the local child health authorities.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Diagnosis of atopic dermatitis, allergic asthma, allergic rhinitis.;Main Objective: To study if oral supplement with vitamins A and D in infancy will increase the cumulative incidence of atopic diseases up to 6 years of age.;Secondary Objective: To study if there is a correlation between vitamin intake and serum IgE and between vitamin D intake and presence of specific IgE against aero- and food allergens. To study if serum IgE levels correlate to serum levels of 25-OH-vitD3 (calcidiol). To find out if reduced oral supplement of vitamin D in infancy will give clinical signs of vitamin D deficiency and if there is a correlation to serum levels of calcidiol.	—

Measure

Time frame

Primary end point(s): Diagnosis of atopic dermatitis, allergic asthma, allergic rhinitis.;Main Objective: To study if oral supplement with vitamins A and D in infancy will increase the cumulative incidence of atopic diseases up to 6 years of age.;Secondary Objective: To study if there is a correlation between vitamin intake and serum IgE and between vitamin D intake and presence of specific IgE against aero- and food allergens. To study if serum IgE levels correlate to serum levels of 25-OH-vitD3 (calcidiol). To find out if reduced oral supplement of vitamin D in infancy will give clinical signs of vitamin D deficiency and if there is a correlation to serum levels of calcidiol.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026