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
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Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborators:
United Arab Emirates University
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
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Tracking Information | |||||||
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First Submitted Date ICMJE | December 27, 2007 | ||||||
First Posted Date ICMJE | February 8, 2008 | ||||||
Results First Submitted Date | May 15, 2012 | ||||||
Results First Posted Date | 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 |
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
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Original Primary Outcome Measures ICMJE |
Maternal and neonatal serum 25-hydroxyvitamin D measurement [ Time Frame: 29 weeks ] | ||||||
Change History | Complete list of historical versions of study NCT00610688 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Growth of the newborn infant as measured by weight, crown-heel length and head circumference at birth [ Time Frame: At delivery ] | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | 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 | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Prevention |
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Condition ICMJE | Vitamin D Deficiency | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
192 | ||||||
Original Estimated Enrollment ICMJE |
180 | ||||||
Actual Study Completion Date | April 2012 | ||||||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 45 Years (Adult) | ||||||
Accepts Healthy Volunteers | 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 | Not Provided | ||||||
Responsible Party | Children's Hospital Medical Center, Cincinnati | ||||||
Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |