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

This study has been completed.
Sponsor:
Collaborators:
United Arab Emirates University
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00610688
First received: December 27, 2007
Last updated: June 5, 2013
Last verified: June 2013
History of Changes

December 27, 2007
June 5, 2013
January 2008
June 2011   (final data collection date for primary outcome measure)
Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement [ Time Frame: 29 weeks ] [ Designated as safety issue: No ]
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
Maternal and neonatal serum 25-hydroxyvitamin D measurement [ Time Frame: 29 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00610688 on ClinicalTrials.gov Archive Site
  • Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Growth of the Newborn Infant as Measured by Birthweight in grams.
Growth of the newborn infant as measured by weight, crown-heel length and head circumference at birth [ Time Frame: At delivery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Vitamin D Deficiency
  • 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
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
April 2012
June 2011   (final data collection date for primary outcome measure)

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.)
Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   United Arab Emirates
 
NCT00610688
PA 03-103
Yes
Not Provided
Not Provided
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
  • United Arab Emirates University
  • Thrasher Research Fund
Principal Investigator: Adekunle Dawodu, MBBS Children's Hospital Medical Center, Cincinnati
Principal Investigator: Hussein F Saadi, MD United Arab Emirates University
Children's Hospital Medical Center, Cincinnati
June 2013

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