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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01723852
Other study ID # VIDI-2012-01
Secondary ID
Status Completed
Phase N/A
First received November 6, 2012
Last updated November 20, 2017
Start date January 2013
Est. completion date November 20, 2017

Study information

Verified date November 2017
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vitamin D at 30 ug/day

Vitamin D at 10 ug/day


Locations

Country Name City State
Finland Kätilöopisto Maternity Hospital Helsinki

Sponsors (4)

Lead Sponsor Collaborator
Helsinki University Central Hospital Finska Läkaresällskapet, Päivikki and Sakari Sohlberg Foundation, Finland, The Finnish Governmental Special Subsidy for Health Sciences Research

Country where clinical trial is conducted

Finland, 

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Primary Growth Measurement of growth at 2 years of age 2 years of age
Primary 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 At 2 years of age
Primary 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. At 2 years of age
Primary 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. At 2 years of age
Primary Bone mineral density Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography 2 years of age
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