Vitamin D Intervention in Infants

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D Intervention in Infants

Conditions
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Vitamin D Status

Intervention / Treatment
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* Dietary Supplement: Vitamin D at 30 ug/day
* Dietary Supplement: Vitamin D at 10 ug/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study Exclusion Criteria: Non Caucasian mother Any continuous regular medication of mother Treatment at neonatal intensive care unit Antibiotic treatment of the infant Congenital malformations of the newborn Treatment with ventilation support (continuous nasal positive airway pressure) for over 24 hours Glucose infusion of the newborn Neurological symptoms of the newborn Phototherapy for jaundice of the newborn Need for nasogastric feeding of the newborn

Ages Eligible for Study
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Maximum Age: 5 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D supplement<br>Vitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age | Dietary Supplement: Vitamin D at 10 ug/day<br> <br> |
| Active Comparator: Vitamin D supplement at 30 ug/day<br>Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age | Dietary Supplement: Vitamin D at 30 ug/day<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | Measurement of growth at 2 years of age | 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 | 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. | 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. | At 2 years of age | 
| Bone mineral density | Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography | 2 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Infectious diseases, cognitive development, Bone mineral density, Immunoregulation, Allergy, Growth