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Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

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ClinicalTrials.gov Identifier: NCT00610688
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Collaborators:
United Arab Emirates University
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE December 27, 2007
First Posted Date  ICMJE February 8, 2008
Results First Submitted Date  ICMJE May 15, 2012
Results First Posted Date  ICMJE June 7, 2013
Last Update Posted Date June 7, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement [ Time Frame: 29 weeks ]
Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2008)
Maternal and neonatal serum 25-hydroxyvitamin D measurement [ Time Frame: 29 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
  • Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth [ Time Frame: At delivery ]
    Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth
  • Birthweight of Newborn Infant [ Time Frame: Measured at birth. ]
    Growth of the Newborn Infant as Measured by Birthweight in grams.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2008)
Growth of the newborn infant as measured by weight, crown-heel length and head circumference at birth [ Time Frame: At delivery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Official Title  ICMJE High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Brief Summary The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.
Detailed Description Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • Drug: Prenatal Vitamin
    Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
  • Drug: Cholecalciferol (Vitamin D3)
    Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
  • Drug: Cholecalciferol (Vitamin D3)
    Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
Study Arms  ICMJE
  • Placebo Comparator: Prenatal Vitamin D3
    Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D
    Intervention: Drug: Prenatal Vitamin
  • Experimental: 2
    Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
    Interventions:
    • Drug: Prenatal Vitamin
    • Drug: Cholecalciferol (Vitamin D3)
  • Experimental: 3
    Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).
    Interventions:
    • Drug: Prenatal Vitamin
    • Drug: Cholecalciferol (Vitamin D3)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2013)
192
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2008)
180
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women who are within the ages of 18-45 years
  • In good general health
  • 12 weeks pregnant (based on last menstrual period)

Exclusion Criteria:

  • Mothers with preexisting type I or type II diabetes
  • Mothers with preexisting hypertension
  • Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
  • Mothers with multiple fetuses (e.g., twins, triplets, etc.)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Arab Emirates,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00610688
Other Study ID Numbers  ICMJE PA 03-103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE
  • United Arab Emirates University
  • Thrasher Research Fund
Investigators  ICMJE
Principal Investigator: Adekunle Dawodu, MBBS Children's Hospital Medical Center, Cincinnati
Principal Investigator: Hussein F Saadi, MD United Arab Emirates University
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP