A Randomized, Double Blind, Comparative Study Of STATUS D3Ⓡ (vitamin D3) Versus Placebo In Children Aged Between 7 And 15 Years Old to prevent infectious diseases including influenza and to improve atopic dermatitis

UMIN ID: UMIN000001373

Registered date:01/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: elementary shool, junior high school children
• Date of first enrollment: 2008/11/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

vitamin D3
placebo

Outcome(s)

• Primary Outcome: doctor-diagnosed influenza
• Secondary Outcome: gastric enteritis, febrile diseases, admission to hospital, absent days from school, changes of child behavior check list and improvement of atopic dermatitis

Key inclusion & exclusion criteria

• Age minimum: 6years-old
• Age maximum: 15years-old
• Gender: Male and Female
• Exclude criteria: 1. already taking vitamin D3 or active form of vitamin D 2. past history of urethral stone, or having underlying diseases related with calcium and/or bone metabolism 3. known allergy to sesame, gelatin, d-solvitor, 4. difficulty in swallowing capsules for 4 months 5. during or within 1 year after chemotherapy or immunocompromised conditions 6. known to move during study period 7. other reasons that doctor judges impossible to attend the study

Related Information

• Primary Sponsor: Jikei University School of Medicine
• Source(s) of Monetary Support: Jikei University School of Medicine