The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,000
Kätilöopisto Maternity Hospital
Helsinki, Finland
Growth
Measurement of growth at 2 years of age
Time frame: 2 years of age
Neurologic and cognitive development
By means of questionnaires and, on a randomly selected group of study subjects, cognitive function testing to assess neurologic and cognitive development
Time frame: At 2 years of age
Frequency of allergic symptoms and infection
Assessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data.
Time frame: At 2 years of age
Development of immunoregulation
Assessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects.
Time frame: At 2 years of age
Bone mineral density
Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography
Time frame: 2 years of age
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