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Vitamin D Intervention in Infants (VIDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01723852
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : November 21, 2017
Sponsor:
Collaborators:
The Finnish Governmental Special Subsidy for Health Sciences Research
Päivikki and Sakari Sohlberg Foundation, Finland
The Finnish Medical Association
Information provided by (Responsible Party):
Sture Andersson, 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.

Condition or disease Intervention/treatment Phase
Vitamin D Status Dietary Supplement: Vitamin D at 30 ug/day Dietary Supplement: Vitamin D at 10 ug/day Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Intervention in Infants
Actual Study Start Date : January 2013
Actual Primary Completion Date : July 15, 2016
Actual Study Completion Date : November 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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



Primary Outcome Measures :
  1. Growth [ Time Frame: 2 years of age ]
    Measurement of growth at 2 years of age

  2. 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

  3. 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.

  4. 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.

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723852


Locations
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Finland
Kätilöopisto Maternity Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
The Finnish Governmental Special Subsidy for Health Sciences Research
Päivikki and Sakari Sohlberg Foundation, Finland
The Finnish Medical Association
Investigators
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Principal Investigator: Sture Andersson, MD, PhD Helsinki University Central Hospital, Children's Hospital
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sture Andersson, Professor of Neonatology, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01723852    
Other Study ID Numbers: VIDI-2012-01
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Keywords provided by Sture Andersson, Helsinki University Central Hospital:
Vitamin D
Infectious diseases
cognitive development
Bone mineral density
Immunoregulation
Allergy
Growth
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents