<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/NCT02186028</url>
  </required_header>
  <id_info>
    <org_study_id>LHMC/094/2012/VitD</org_study_id>
    <nct_id>NCT02186028</nct_id>
  </id_info>
  <brief_title>Effect of Oral Daily Supplementation With 400 IU Vs 200 IU of Vitamin D in Term Healthy Neonates</brief_title>
  <official_title>Effect Of Oral Daily Supplementation With 400 IU Vs 200 IU Of Vitamin D In Term Healthy Newborns: A Randomised Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lady Hardinge Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lady Hardinge Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the effect of daily oral supplementation with vitamin&#xD;
      D on serum Vitamin D levels in term healthy newborns. It has been found in various studies&#xD;
      that vitamin D is highly deficient in Indian mother infant diads. There is a need to&#xD;
      supplement vitamin D from neonatal period to prevent various metabolic disturbances due to&#xD;
      vitamin D deficiency in later life. This study aims to find the effectiveness and the optimum&#xD;
      dose of routine vitamin D supplementation in healthy term newborns for fulfilling the normal&#xD;
      requirements in Indian infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D deficiency is highly prevalent in India as reported in various studies. Vitamin D&#xD;
      supplementation is necessary as vitamin D is required not only for prevention of rickets as&#xD;
      traditionally thought, but also for its emerging role in development of diseases such as&#xD;
      myopathic disorders, proneness to infection, autoimmune disorders and cancers .However&#xD;
      supplementation studies are limited and predominantly from foreign countries. Moreover most&#xD;
      of them report variable outcomes with no unanimous outcome with respect to optimum dose and&#xD;
      duration of supplementation of vitamin D. Various national authorities recommend different&#xD;
      doses of vitamin D for supplementation. American Academy of Pediatrics, The Institute of&#xD;
      Medicine of National Academics, The Drug and Therapeutics Committee of the Lawson Wilkins&#xD;
      Pediatric Endocrine Society, the Canadian Pediatric Society and European Society for&#xD;
      Pediatric Endocrinology recommend that 400IU of vitamin D should be supplemented in all&#xD;
      infants starting from within a few days of birth throughout childhood. ESPGHAN recommends&#xD;
      800-1000 IU for high risk infants, Ireland recommends 200IU vitamin D per day, UK does not&#xD;
      recommend any supplements upto 6 months of age , however if formula milk intake &lt;500ml/day&#xD;
      then 300 IU is recommended. There are no such guidelines for India. Hence this study aims at&#xD;
      evaluating the proportion of vitamin D deficient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in vitamin D levels attained after oral supplementation with 400IU/day Vs 200IU/day of vitamin D for 6 months</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of vitamin D deficient term healthy neonates at birth</measure>
    <time_frame>at birth</time_frame>
    <description>serum vitaminD levels &gt; 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient &lt;15 ng/ml - deficient</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of neonates having vitamin D sufficiency after supplementation</measure>
    <time_frame>6 months</time_frame>
    <description>serum vitamin D levels &gt; 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient &lt;15 ng/ml - deficient</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of neonates having vitamin D deficiency after supplementation</measure>
    <time_frame>6 months</time_frame>
    <description>serum vitamin D levels &gt; 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient &lt;15 ng/ml - deficient</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Vitamin D 400 IU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vitamin D-400IU/ml- 1ml daily&#xD;
Neonates will be administered Vitamin D 400 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D 200IU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vitamin D 400IU/ml : 0.5ml daily&#xD;
Neonates will be administered Vitamin D 200 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Vit D 400 IU vs. Vit D 200 IU</description>
    <arm_group_label>Vitamin D 200IU</arm_group_label>
    <arm_group_label>Vitamin D 400 IU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestation &gt; 37 weeks&#xD;
&#xD;
          -  Birth weight &gt;2.5 kg&#xD;
&#xD;
          -  Informed consent of one of the parents&#xD;
&#xD;
          -  Place of residence&lt;10km&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of gross congenital malformation&#xD;
&#xD;
          -  Need of resuscitation at birth&#xD;
&#xD;
          -  Need for admission to neonatal ICU&#xD;
&#xD;
          -  Refusal of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Hours</minimum_age>
    <maximum_age>48 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sushma Nangia, MD, DM</last_name>
    <role>Study Chair</role>
    <affiliation>Lady Hardinge Medical College &amp; Kalawati Saran Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arvind Saili, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lady Hardinge Medical College &amp; Kalawati Saran Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kalawati Saran children's Hospital, Lady Hardinge Medical College</name>
      <address>
        <city>New Delhi</city>
        <zip>110001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>September 26, 2015</last_update_submitted>
  <last_update_submitted_qc>September 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lady Hardinge Medical College</investigator_affiliation>
    <investigator_full_name>Sushma Nangia, M.D.</investigator_full_name>
    <investigator_title>Dr Sushma Nangia, M.D., D.M. (neonatology)</investigator_title>
  </responsible_party>
  <keyword>oral daily supplementation with vitamin D for 6 months</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</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/NCT02186028
org study id: LHMC/094/2012/VitD
nct id: NCT02186028
lead sponsor: 
has dmc: Yes
The purpose of the study is to evaluate the effect of daily oral supplementation with vitamin
      D on serum Vitamin D levels in term healthy newborns. It has been found in various studies
      that vitamin D is highly deficient in Indian mother infant diads. There is a need to
      supplement vitamin D from neonatal period to prevent various metabolic disturbances due to
      vitamin D deficiency in later life. This study aims to find the effectiveness and the optimum
      dose of routine vitamin D supplementation in healthy term newborns for fulfilling the normal
      requirements in Indian infants.
Vitamin D deficiency is highly prevalent in India as reported in various studies. Vitamin D
      supplementation is necessary as vitamin D is required not only for prevention of rickets as
      traditionally thought, but also for its emerging role in development of diseases such as
      myopathic disorders, proneness to infection, autoimmune disorders and cancers .However
      supplementation studies are limited and predominantly from foreign countries. Moreover most
      of them report variable outcomes with no unanimous outcome with respect to optimum dose and
      duration of supplementation of vitamin D. Various national authorities recommend different
      doses of vitamin D for supplementation. American Academy of Pediatrics, The Institute of
      Medicine of National Academics, The Drug and Therapeutics Committee of the Lawson Wilkins
      Pediatric Endocrine Society, the Canadian Pediatric Society and European Society for
      Pediatric Endocrinology recommend that 400IU of vitamin D should be supplemented in all
      infants starting from within a few days of birth throughout childhood. ESPGHAN recommends
      800-1000 IU for high risk infants, Ireland recommends 200IU vitamin D per day, UK does not
      recommend any supplements upto 6 months of age , however if formula milk intake <500ml/day
      then 300 IU is recommended. There are no such guidelines for India. Hence this study aims at
      evaluating the proportion of vitamin D deficient
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Difference in vitamin D levels attained after oral supplementation with 400IU/day Vs 200IU/day of vitamin D for 6 months
time frame: 6 months
measure: Proportion of vitamin D deficient term healthy neonates at birth
time frame: at birth
description: serum vitaminD levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient
measure: Proportion of neonates having vitamin D sufficiency after supplementation
time frame: 6 months
description: serum vitamin D levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient
measure: Proportion of neonates having vitamin D deficiency after supplementation
time frame: 6 months
description: serum vitamin D levels > 20 ng/ml - sufficient 15 - 20 ng/ml - insufficient <15 ng/ml - deficient
arm group label: Vitamin D 400 IU
arm group type: Experimental
description: Vitamin D-400IU/ml- 1ml daily
Neonates will be administered Vitamin D 400 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age.
arm group label: Vitamin D 200IU
arm group type: Active Comparator
description: Vitamin D 400IU/ml : 0.5ml daily
Neonates will be administered Vitamin D 200 IU orally daily by the mother or other caregiver for a period of six months. The neonates will be followed up for compliance at 2 weeks, 6, 10 and 14 weeks and thereafter at 6 months of age.
intervention type: Drug
intervention name: Vitamin D
description: Vit D 400 IU vs. Vit D 200 IU
arm group label: Vitamin D 200IU
arm group label: Vitamin D 400 IU
criteria: 
gender: All
minimum age: 2 Hours
maximum age: 48 Hours
healthy volunteers: Accepts Healthy Volunteers
last name: Sushma Nangia, MD, DM
role: Study Chair
affiliation: Lady Hardinge Medical College & Kalawati Saran Children's Hospital
last name: Arvind Saili, MD
role: Study Director
affiliation: Lady Hardinge Medical College & Kalawati Saran Children's Hospital
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Lady Hardinge Medical College
investigator full name: Sushma Nangia, M.D.
investigator title: Dr Sushma Nangia, M.D., D.M. (neonatology)
mesh term: Vitamin D Deficiency
mesh term: Vitamin D