<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01723852</url>
  </required_header>
  <id_info>
    <org_study_id>VIDI-2012-01</org_study_id>
    <nct_id>NCT01723852</nct_id>
  </id_info>
  <brief_title>Vitamin D Intervention in Infants</brief_title>
  <acronym>VIDI</acronym>
  <official_title>Vitamin D Intervention in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Finnish Governmental Special Subsidy for Health Sciences Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Päivikki and Sakari Sohlberg Foundation, Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Finnish Medical Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a randomized, controlled, double blinded study evaluating the effect of&#xD;
      recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years&#xD;
      of age, on growth, bone development, neurologic and cognitive development, frequence of&#xD;
      infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2&#xD;
      years of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">November 20, 2017</completion_date>
  <primary_completion_date type="Actual">July 15, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Growth</measure>
    <time_frame>2 years of age</time_frame>
    <description>Measurement of growth at 2 years of age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurologic and cognitive development</measure>
    <time_frame>At 2 years of age</time_frame>
    <description>By means of questionnaires and, on a randomly selected group of study subjects, cognitive function testing to assess neurologic and cognitive development</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of allergic symptoms and infection</measure>
    <time_frame>At 2 years of age</time_frame>
    <description>Assessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Development of immunoregulation</measure>
    <time_frame>At 2 years of age</time_frame>
    <description>Assessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone mineral density</measure>
    <time_frame>2 years of age</time_frame>
    <description>Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Vitamin D Status</condition>
  <arm_group>
    <arm_group_label>Vitamin D supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D supplement at 30 ug/day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D at 30 ug/day</intervention_name>
    <arm_group_label>Vitamin D supplement at 30 ug/day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D at 10 ug/day</intervention_name>
    <arm_group_label>Vitamin D supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born at term (37-42 wks, weight appropriate for gestational age) are included&#xD;
             in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non Caucasian mother&#xD;
&#xD;
          -  Any continuous regular medication of mother&#xD;
&#xD;
          -  Treatment at neonatal intensive care unit&#xD;
&#xD;
          -  Antibiotic treatment of the infant&#xD;
&#xD;
          -  Congenital malformations of the newborn&#xD;
&#xD;
          -  Treatment with ventilation support (continuous nasal positive airway pressure) for&#xD;
             over 24 hours&#xD;
&#xD;
          -  Glucose infusion of the newborn&#xD;
&#xD;
          -  Neurological symptoms of the newborn&#xD;
&#xD;
          -  Phototherapy for jaundice of the newborn&#xD;
&#xD;
          -  Need for nasogastric feeding of the newborn&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sture Andersson, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki University Central Hospital, Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kätilöopisto Maternity Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <reference>
    <citation>Holmlund-Suila E, Viljakainen H, Hytinantti T, Lamberg-Allardt C, Andersson S, Makitie O. High-dose vitamin d intervention in infants--effects on vitamin d status, calcium homeostasis, and bone strength. J Clin Endocrinol Metab. 2012 Nov;97(11):4139-47. doi: 10.1210/jc.2012-1575. Epub 2012 Aug 29. Erratum In: J Clin Endocrinol Metab. 2023 Aug 18;108(9):e905.</citation>
    <PMID>22933541</PMID>
  </reference>
  <reference>
    <citation>Helve O, Viljakainen H, Holmlund-Suila E, Rosendahl J, Hauta-Alus H, Enlund-Cerullo M, Valkama S, Heinonen K, Raikkonen K, Hytinantti T, Makitie O, Andersson S. Towards evidence-based vitamin D supplementation in infants: vitamin D intervention in infants (VIDI) - study design and methods of a randomised controlled double-blinded intervention study. BMC Pediatr. 2017 Mar 29;17(1):91. doi: 10.1186/s12887-017-0845-5.</citation>
    <PMID>28356142</PMID>
  </reference>
  <results_reference>
    <citation>Rosendahl J, Holmlund-Suila E, Helve O, Viljakainen H, Hauta-Alus H, Valkama S, Enlund-Cerullo M, Hytinantti T, Tervahartiala T, Sorsa T, Makitie O, Andersson S. 25-hydroxyvitamin D correlates with inflammatory markers in cord blood of healthy newborns. Pediatr Res. 2017 May;81(5):731-735. doi: 10.1038/pr.2017.9. Epub 2017 Jan 13.</citation>
    <PMID>28085793</PMID>
  </results_reference>
  <results_reference>
    <citation>Hauta-Alus HH, Holmlund-Suila EM, Rita HJ, Enlund-Cerullo M, Rosendahl J, Valkama SM, Helve OM, Hytinantti TK, Surcel HM, Makitie OM, Andersson S, Viljakainen HT. Season, dietary factors, and physical activity modify 25-hydroxyvitamin D concentration during pregnancy. Eur J Nutr. 2018 Jun;57(4):1369-1379. doi: 10.1007/s00394-017-1417-z. Epub 2017 Mar 2.</citation>
    <PMID>28255653</PMID>
  </results_reference>
  <results_reference>
    <citation>Valkama S, Holmlund-Suila E, Enlund-Cerullo M, Rosendahl J, Hauta-Alus H, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. No Severe Hypercalcemia with Daily Vitamin D3 Supplementation of up to 30 microg during the First Year of Life. Horm Res Paediatr. 2017;88(2):147-154. doi: 10.1159/000477298. Epub 2017 Jun 23.</citation>
    <PMID>28647736</PMID>
  </results_reference>
  <results_reference>
    <citation>Holmlund-Suila E, Enlund-Cerullo M, Valkama S, Hauta-Alus H, Rosendahl J, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. Sex and Iron Modify Fibroblast Growth Factor 23 Concentration in 1-Year-Old Children. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4526-4533. doi: 10.1210/jc.2017-01211.</citation>
    <PMID>29029193</PMID>
  </results_reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>November 20, 2017</last_update_submitted>
  <last_update_submitted_qc>November 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Sture Andersson</investigator_full_name>
    <investigator_title>Professor of Neonatology</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Infectious diseases</keyword>
  <keyword>cognitive development</keyword>
  <keyword>Bone mineral density</keyword>
  <keyword>Immunoregulation</keyword>
  <keyword>Allergy</keyword>
  <keyword>Growth</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01723852
org study id: VIDI-2012-01
nct id: NCT01723852
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Growth
time frame: 2 years of age
description: Measurement of growth at 2 years of age
measure: Neurologic and cognitive development
time frame: At 2 years of age
description: By means of questionnaires and, on a randomly selected group of study subjects, cognitive function testing to assess neurologic and cognitive development
measure: Frequency of allergic symptoms and infection
time frame: At 2 years of age
description: Assessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data.
measure: Development of immunoregulation
time frame: At 2 years of age
description: Assessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects.
measure: Bone mineral density
time frame: 2 years of age
description: Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography
arm group label: Vitamin D supplement
arm group type: Active Comparator
description: Vitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age
arm group label: Vitamin D supplement at 30 ug/day
arm group type: Active Comparator
description: Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age
intervention type: Dietary Supplement
intervention name: Vitamin D at 30 ug/day
arm group label: Vitamin D supplement at 30 ug/day
intervention type: Dietary Supplement
intervention name: Vitamin D at 10 ug/day
arm group label: Vitamin D supplement
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Sture Andersson, MD, PhD
role: Principal Investigator
affiliation: Helsinki University Central Hospital, Children's Hospital
facility: 
country: Finland
citation: Holmlund-Suila E, Viljakainen H, Hytinantti T, Lamberg-Allardt C, Andersson S, Makitie O. High-dose vitamin d intervention in infants--effects on vitamin d status, calcium homeostasis, and bone strength. J Clin Endocrinol Metab. 2012 Nov;97(11):4139-47. doi: 10.1210/jc.2012-1575. Epub 2012 Aug 29. Erratum In: J Clin Endocrinol Metab. 2023 Aug 18;108(9):e905.
PMID: 22933541
citation: Helve O, Viljakainen H, Holmlund-Suila E, Rosendahl J, Hauta-Alus H, Enlund-Cerullo M, Valkama S, Heinonen K, Raikkonen K, Hytinantti T, Makitie O, Andersson S. Towards evidence-based vitamin D supplementation in infants: vitamin D intervention in infants (VIDI) - study design and methods of a randomised controlled double-blinded intervention study. BMC Pediatr. 2017 Mar 29;17(1):91. doi: 10.1186/s12887-017-0845-5.
PMID: 28356142
citation: Rosendahl J, Holmlund-Suila E, Helve O, Viljakainen H, Hauta-Alus H, Valkama S, Enlund-Cerullo M, Hytinantti T, Tervahartiala T, Sorsa T, Makitie O, Andersson S. 25-hydroxyvitamin D correlates with inflammatory markers in cord blood of healthy newborns. Pediatr Res. 2017 May;81(5):731-735. doi: 10.1038/pr.2017.9. Epub 2017 Jan 13.
PMID: 28085793
citation: Hauta-Alus HH, Holmlund-Suila EM, Rita HJ, Enlund-Cerullo M, Rosendahl J, Valkama SM, Helve OM, Hytinantti TK, Surcel HM, Makitie OM, Andersson S, Viljakainen HT. Season, dietary factors, and physical activity modify 25-hydroxyvitamin D concentration during pregnancy. Eur J Nutr. 2018 Jun;57(4):1369-1379. doi: 10.1007/s00394-017-1417-z. Epub 2017 Mar 2.
PMID: 28255653
citation: Valkama S, Holmlund-Suila E, Enlund-Cerullo M, Rosendahl J, Hauta-Alus H, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. No Severe Hypercalcemia with Daily Vitamin D3 Supplementation of up to 30 microg during the First Year of Life. Horm Res Paediatr. 2017;88(2):147-154. doi: 10.1159/000477298. Epub 2017 Jun 23.
PMID: 28647736
citation: Holmlund-Suila E, Enlund-Cerullo M, Valkama S, Hauta-Alus H, Rosendahl J, Helve O, Hytinantti T, Viljakainen H, Andersson S, Makitie O. Sex and Iron Modify Fibroblast Growth Factor 23 Concentration in 1-Year-Old Children. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4526-4533. doi: 10.1210/jc.2017-01211.
PMID: 29029193
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Sture Andersson
investigator title: Professor of Neonatology
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins