<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/NCT02215213</url>
  </required_header>
  <id_info>
    <org_study_id>PF8/0911</org_study_id>
    <nct_id>NCT02215213</nct_id>
  </id_info>
  <brief_title>Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial</brief_title>
  <official_title>Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the&#xD;
      study participants will receive Vitamin D in supplement form. Pregnant women will be&#xD;
      individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till&#xD;
      the time of delivery.A blood sample will also be collected from the participant at the time&#xD;
      of recruitment /before the starting of the supplementation for the assessment of Calcium,&#xD;
      Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D&#xD;
      level to assess vitamin D status will be done after completion of the supplementation phase&#xD;
      at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan&#xD;
      University laboratory&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that Pakistani mothers as darkly pigmented, will require&#xD;
      substantially higher oral supplementation with vitamin D to replenish the micronutrient&#xD;
      stores and aid to resolve associated maternal and neonatal morbidity due to Vitamin D&#xD;
      deficiency. The investigators expect that if vitamin D is supplemented to pregnant women,&#xD;
      their newborn infants would inevitably replenish the micronutrient stores and aid to resolve&#xD;
      the maternal and neonatal morbidity due to Vitamin D deficiency.This is hospital based double&#xD;
      blinded trial, study participants divided into three groups which will receive Vitamin D&#xD;
      supplementation in 400, 2000 and 4000 International Units. The group which will receive 400&#xD;
      IUs will be treated as control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pregnancy out come</measure>
    <time_frame>At delivery of neonate</time_frame>
    <description>Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of vitamin D deficiency in pregnant women</measure>
    <time_frame>at recruitment into study (first trimester)</time_frame>
    <description>Maternal vitamin D deficiency in the target group.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 1 is receiving vitamin D supplementation in 2000 IU/day ,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 2 is receiving vitamin D supplementation in 4000/IU per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3 control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 3 is receiving vitamin D supplementation in 400 IU/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D supplement</intervention_name>
    <description>comparison of different dosages of vitamin D</description>
    <arm_group_label>Arm 2 intervention group</arm_group_label>
    <arm_group_label>Arm 3 control group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Brand name: Vitamin D3</other_name>
    <other_name>LOT ID AKUH COMPOUNDING 2305012014</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D supplement</intervention_name>
    <description>comparison of different dosages of vitamin D Supplement</description>
    <arm_group_label>Arm 2 intervention group</arm_group_label>
    <arm_group_label>Arm 3 control group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Brand name: Vitamin D3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women aged 15 - 45 years&#xD;
&#xD;
          -  Less than 16 weeks pregnant from Last menstrual period.&#xD;
&#xD;
          -  Agree to take part in this study, will be enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with pre existing type 1 or type II diabetes,&#xD;
&#xD;
          -  Pregnant women with pre existing hypertension&#xD;
&#xD;
          -  Women with multiple fetuses, babies (twins, triplets)&#xD;
&#xD;
          -  Women with fetal anomaly in scan&#xD;
&#xD;
          -  Refuse to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sidrah Nausheen, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aga Khan University</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>75300</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <results_reference>
    <citation>Farrant HJ, Krishnaveni GV, Hill JC, Boucher BJ, Fisher DJ, Noonan K, Osmond C, Veena SR, Fall CH. Vitamin D insufficiency is common in Indian mothers but is not associated with gestational diabetes or variation in newborn size. Eur J Clin Nutr. 2009 May;63(5):646-52. doi: 10.1038/ejcn.2008.14. Epub 2008 Feb 20.</citation>
    <PMID>18285809</PMID>
  </results_reference>
  <results_reference>
    <citation>Bodnar LM, Catov JM, Roberts JM, Simhan HN. Prepregnancy obesity predicts poor vitamin D status in mothers and their neonates. J Nutr. 2007 Nov;137(11):2437-42. doi: 10.1093/jn/137.11.2437.</citation>
    <PMID>17951482</PMID>
  </results_reference>
  <results_reference>
    <citation>Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1. Erratum In: Lancet. 2006 May 6;367(9521):1486.</citation>
    <PMID>16399151</PMID>
  </results_reference>
  <results_reference>
    <citation>Gale CR, Robinson SM, Harvey NC, Javaid MK, Jiang B, Martyn CN, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and child outcomes. Eur J Clin Nutr. 2008 Jan;62(1):68-77. doi: 10.1038/sj.ejcn.1602680. Epub 2007 Feb 21.</citation>
    <PMID>17311057</PMID>
  </results_reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>July 15, 2016</last_update_submitted>
  <last_update_submitted_qc>July 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Dr Sidrah Nausheen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>pregnancy</keyword>
  <keyword>Pakistan</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/NCT02215213
org study id: PF8/0911
nct id: NCT02215213
lead sponsor: 
has dmc: No
The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the
      study participants will receive Vitamin D in supplement form. Pregnant women will be
      individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till
      the time of delivery.A blood sample will also be collected from the participant at the time
      of recruitment /before the starting of the supplementation for the assessment of Calcium,
      Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D
      level to assess vitamin D status will be done after completion of the supplementation phase
      at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan
      University laboratory
The investigators hypothesize that Pakistani mothers as darkly pigmented, will require
      substantially higher oral supplementation with vitamin D to replenish the micronutrient
      stores and aid to resolve associated maternal and neonatal morbidity due to Vitamin D
      deficiency. The investigators expect that if vitamin D is supplemented to pregnant women,
      their newborn infants would inevitably replenish the micronutrient stores and aid to resolve
      the maternal and neonatal morbidity due to Vitamin D deficiency.This is hospital based double
      blinded trial, study participants divided into three groups which will receive Vitamin D
      supplementation in 400, 2000 and 4000 International Units. The group which will receive 400
      IUs will be treated as control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: pregnancy out come
time frame: At delivery of neonate
description: Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.
measure: Prevalence of vitamin D deficiency in pregnant women
time frame: at recruitment into study (first trimester)
description: Maternal vitamin D deficiency in the target group.
arm group label: Intervention Group
arm group type: Active Comparator
description: Arm 1 is receiving vitamin D supplementation in 2000 IU/day ,
arm group label: Arm 2 intervention group
arm group type: Active Comparator
description: Arm 2 is receiving vitamin D supplementation in 4000/IU per day
arm group label: Arm 3 control group
arm group type: Active Comparator
description: Arm 3 is receiving vitamin D supplementation in 400 IU/day
intervention type: Drug
intervention name: Vitamin D supplement
description: comparison of different dosages of vitamin D
arm group label: Arm 2 intervention group
arm group label: Arm 3 control group
arm group label: Intervention Group
other name: Brand name: Vitamin D3
other name: LOT ID AKUH COMPOUNDING 2305012014
intervention type: Drug
intervention name: Vitamin D supplement
description: comparison of different dosages of vitamin D Supplement
arm group label: Arm 2 intervention group
arm group label: Arm 3 control group
arm group label: Intervention Group
other name: Brand name: Vitamin D3
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sidrah Nausheen, FCPS
role: Principal Investigator
affiliation: Aga Khan University
facility: 
country: Pakistan
citation: Farrant HJ, Krishnaveni GV, Hill JC, Boucher BJ, Fisher DJ, Noonan K, Osmond C, Veena SR, Fall CH. Vitamin D insufficiency is common in Indian mothers but is not associated with gestational diabetes or variation in newborn size. Eur J Clin Nutr. 2009 May;63(5):646-52. doi: 10.1038/ejcn.2008.14. Epub 2008 Feb 20.
PMID: 18285809
citation: Bodnar LM, Catov JM, Roberts JM, Simhan HN. Prepregnancy obesity predicts poor vitamin D status in mothers and their neonates. J Nutr. 2007 Nov;137(11):2437-42. doi: 10.1093/jn/137.11.2437.
PMID: 17951482
citation: Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1. Erratum In: Lancet. 2006 May 6;367(9521):1486.
PMID: 16399151
citation: Gale CR, Robinson SM, Harvey NC, Javaid MK, Jiang B, Martyn CN, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and child outcomes. Eur J Clin Nutr. 2008 Jan;62(1):68-77. doi: 10.1038/sj.ejcn.1602680. Epub 2007 Feb 21.
PMID: 17311057
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Dr Sidrah Nausheen
investigator title: Principal Investigator
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins