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Improving the Understanding of the Response to Vitamin D Supplementation

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01465178
First received: October 27, 2011
Last updated: October 4, 2016
Last verified: October 2016
Results First Received: August 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Diagnostic
Condition: Vitamin D Deficiency
Interventions: Dietary Supplement: cholecalciferol
Dietary Supplement: Placebo

  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
Enrollment started December 2011 and ended December 2014. Subjects were enrolled from the community and research was conducted at the University of Wisconsin Osteoporosis Clinical Research Program.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No adverse events were reported between screening and randomization. All screened volunteers that were not enrolled in the study were deemed ineligible based on 25(OH)vitamin D being outside the study entry criterion.

Reporting Groups
  Description
2000 IU Vitamin D3

Cholecalciferol 2,000 IU capsules

cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily

Placebo

Non-matching placebo, gelatin filled capsules

Placebo: matching placebo


Participant Flow:   Overall Study
    2000 IU Vitamin D3   Placebo
STARTED   31   31 
COMPLETED   30   31 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  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.
Postmenopausal women with 25(OH)D 10 - 29 ng/ml.

Reporting Groups
  Description
2000 IU Vitamin D3

Cholecalciferol 2,000 IU capsules

cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily

Placebo

Non-matching placebo, gelatin filled capsules

Placebo: matching placebo

Total Total of all reporting groups

Baseline Measures
   2000 IU Vitamin D3   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   31   62 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.7  (9.7)   65.9  (8.2)   67.8  (9.1) 
Gender 
[Units: Participants]
     
Female   31   31   62 
Male   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   31   31   62 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   31   31   62 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   31   31   62 


  Outcome Measures
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1.  Primary:   Change in Serum 25-hydroxy Vitamin D3   [ Time Frame: Baseline, 1 and 4 months post supplementation ]

2.  Secondary:   Change in Parameters of the Vitamin D Assay Panel   [ Time Frame: Baseline, 1 and 4 months post supplementation ]


  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: Neil Binkley
Organization: University of Wisconsin
phone: 608-265-6410
e-mail: nbinkley@wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01465178     History of Changes
Other Study ID Numbers: 2011-0601
Study First Received: October 27, 2011
Results First Received: August 3, 2016
Last Updated: October 4, 2016
Health Authority: United States: Institutional Review Board