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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
Results First Received: May 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Prevention
Condition: Vitamin D Deficiency
Interventions: Drug: Prenatal Vitamin
Drug: Cholecalciferol (Vitamin D3)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
400 IU Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
2000 IU Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
4000 IU Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D

Participant Flow:   Overall Study
    400 IU     2000 IU     4000 IU  
STARTED     64     65     63  
COMPLETED     55     52     55  
NOT COMPLETED     9     13     8  



  Baseline Characteristics
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Reporting Groups
  Description
400 IU Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
2000 IU Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
4000 IU Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
Total Total of all reporting groups

Baseline Measures
    400 IU     2000 IU     4000 IU     Total  
Number of Participants  
[units: participants]
 		  64     65     63     192  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     64     65     63     192  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  27.5  ± 5.5     27.4  ± 4.8     25.7  ± 5.5     26.9  ± 5.3  
Gender  
[units: participants]
 		       
Female     64     65     63     192  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
United Arab Emirates     64     65     63     192  
Maternal serum 25 hydroxy Vitamin D (25(OH)D)  
[units: nmol/L]
Mean ± Standard Deviation 		  21.5  ± 13.0     20.5  ± 11.9     19.6  ± 7.7     20.7  ± 11.6  



  Outcome Measures
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1.  Primary:   Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement   [ Time Frame: 29 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth   [ Time Frame: At delivery ]
  Show Outcome Measure 2

3.  Secondary:   Birthweight of Newborn Infant   [ Time Frame: Measured at birth. ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Adekunle Dawodu
Organization: Cincinnati Children's Hospital Medical Center
phone: 513-636-1966
e-mail: Adekunle.Dawodu@cchmc.org


Publications:


Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00610688     History of Changes
Other Study ID Numbers: PA 03-103
Study First Received: December 27, 2007
Results First Received: May 15, 2012
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United Arab Emirates: General Authority for Health Services for Abu Dhabi