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Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina

This study has been completed.
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Carol Wagner, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00412087
First received: December 13, 2006
Last updated: June 16, 2016
Last verified: June 2016
Results First Received: May 4, 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
Conditions: Vitamin D Deficiency
Pregnancy
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
564 women consented to participate in Aim 1 of the study (collection of cross-sectional baseline measures only). Of those 564 women, 265 were enrolled in Aim 2 of the study; only the Aim 2 cohort were randomized to intervention groups and followed through delivery.

Reporting Groups
  Description
Cholecalciferol 2000 IU

Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Cholecalciferol 4000 IU

Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.


Participant Flow:   Overall Study
    Cholecalciferol 2000 IU   Cholecalciferol 4000 IU
STARTED   134   131 
COMPLETED   72   66 
NOT COMPLETED   62   65 



  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 2000 IU

Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Cholecalciferol 4000 IU

Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day

cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Total Total of all reporting groups

Baseline Measures
   Cholecalciferol 2000 IU   Cholecalciferol 4000 IU   Total 
Overall Participants Analyzed 
[Units: Participants]
 134   131   265 
Age 
[Units: Years]
Mean (Standard Deviation)
 24.4  (5.5)   25.2  (4.8)   24.8  (5.2) 
Gender 
[Units: Participants]
     
Female   134   131   265 
Male   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   25-hydroxyvitamin D at Visit 7   [ Time Frame: 7 months ]

2.  Secondary:   Parathyroid Hormone at Visit 7   [ 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: NCT00412087     History of Changes
Other Study ID Numbers: HR-16476
Study First Received: December 13, 2006
Results First Received: May 4, 2016
Last Updated: June 16, 2016
Health Authority: United States: Food and Drug Administration