Vitamin D Intervention in Infants (VIDI)

November 20, 2017 updated by: Sture Andersson, Helsinki University Central Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Kätilöopisto Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D supplement
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
Active Comparator: Vitamin D supplement at 30 ug/day
Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age
Dietary supplement: Vitamin D at 30 ug/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: 2 years of age
Measurement of growth at 2 years of age
2 years of age
Neurologic and cognitive development
Time Frame: 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
At 2 years of age
Frequency of allergic symptoms and infection
Time Frame: At 2 years of age
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
Time Frame: 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.
At 2 years of age
Bone mineral density
Time Frame: 2 years of age
Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography
2 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

The Finnish Medical Association
The Finnish Governmental Special Subsidy for Health Sciences Research
Päivikki and Sakari Sohlberg Foundation, Finland

Investigators

  • Principal Investigator: Sture Andersson, MD, PhD, Helsinki University Central Hospital, Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

July 15, 2016

Study Completion (Actual)

November 20, 2017

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 8, 2012

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIDI-2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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