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Evaluation of Vitamin D Requirements During Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Carol Wagner, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00292591
First received: February 15, 2006
Last updated: August 9, 2016
Last verified: August 2016
Results First Received: June 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Vitamin D Deficiency
Interventions: Drug: cholecalciferol (vitamin D3)
Drug: cholecalciferol

  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
Cholecalciferol-400 IU

Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day

cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day

cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy

Cholecalciferol 2000 IU

Experimental group receiving 2000 IU total vitamin D3/day.

cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day

cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy

Cholecalciferol 4000 IU

Experimental group receiving 4000 IU/day cholecalciferol

cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day

cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy


Participant Flow:   Overall Study
    Cholecalciferol-400 IU   Cholecalciferol 2000 IU   Cholecalciferol 4000 IU
STARTED   166   167   168 
COMPLETED   102   111   110 
NOT COMPLETED   64   56   58 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cholecalciferol-400 IU

Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day

cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day

cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy

Cholecalciferol 2000 IU

Experimental group receiving 2000 IU total vitamin D3/day.

cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day

cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy

Cholecalciferol 4000 IU

Experimental group receiving 4000 IU/day cholecalciferol

cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day

cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy

Total Total of all reporting groups

Baseline Measures
   Cholecalciferol-400 IU   Cholecalciferol 2000 IU   Cholecalciferol 4000 IU   Total 
Overall Participants Analyzed 
[Units: Participants]
 166   167   168   501 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.4  (5.6)   26.7  (5.5)   26.4  (5.4)   26.5  (5.5) 
Gender 
[Units: Participants]
       
Female   166   167   168   501 
Male   0   0   0   0 


  Outcome Measures

1.  Primary:   25-Hydroxyvitamin D Concentration   [ Time Frame: 7 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Carol Wagner
Organization: Medical University of South Carolina
phone: 18437922112
e-mail: wagnercl@musc.edu


Publications of Results:
Other Publications:

Responsible Party: Carol Wagner, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00292591     History of Changes
Other Study ID Numbers: R01HD043921 ( US NIH Grant/Contract Award Number )
5R01HD043921 ( US NIH Grant/Contract Award Number )
Study First Received: February 15, 2006
Results First Received: June 28, 2016
Last Updated: August 9, 2016
Health Authority: United States: Food and Drug Administration