Vitamin D Intervention in Infants

Not Applicable

Completed

• Conditions: Vitamin D Status
• Interventions: Dietary Supplement: Vitamin D at 10 ug/day; Dietary Supplement: Vitamin D at 30 ug/day

• Registration Number: NCT01723852
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-07
• Study First Posted: 2012-11-08
• Study Start: 2013-01
• Primary Completion: 2016-07-15
• Status Verified: 2017-11
• Study Completion: 2017-11-20
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D supplement	Vitamin D at 10 ug/day	Vitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age
Vitamin D supplement at 30 ug/day	Vitamin D at 30 ug/day	Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age

Primary Outcome Measures

Name	Time	Method
Growth	2 years of age	Measurement of growth at 2 years of age
Neurologic and cognitive development	At 2 years of age	By means of questionnaires and, on a randomly selected group of study subjects, cognitive function testing to assess neurologic and cognitive development
Frequency of allergic symptoms and infection	At 2 years of age	Assessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data.
Development of immunoregulation	At 2 years of age	Assessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects.
Bone mineral density	2 years of age	Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography

Trial Locations

Locations (1)

Kätilöopisto Maternity Hospital; 🇫🇮 Helsinki, Finland