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hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742235
First Posted: August 27, 2008
Last Update Posted: April 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ishir Bhan, MD, MPH, Massachusetts General Hospital
Results First Submitted: June 5, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Healthy Subjects
Vitamin D Deficiency
Intervention: Drug: ergocalciferol

  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
Healthy subjects were recruited via flyer to a clinical research center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were excluded for eGFR<60, hypercalcemia, history of nephrolithiasis.

Reporting Groups
  Description
Vitamin D Sufficient Subjects not treated with ergocalciferol and who had 25-OH vitamin D > 32 ng/ml.
Vitamin D Insufficient Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL who were offered ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total)

Participant Flow:   Overall Study
    Vitamin D Sufficient   Vitamin D Insufficient
STARTED   32   67 
COMPLETED   32   36 
NOT COMPLETED   0   31 
Lost to Follow-up                0                31 



  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
Vitamin D Sufficient Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
Vitamin D Insufficient Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
Total Total of all reporting groups

Baseline Measures
   Vitamin D Sufficient   Vitamin D Insufficient   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   67   99 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   32   66   98 
>=65 years   0   1   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.1  (14.9)   36.7  (12.5)   36.5  (13.3) 
Gender 
[Units: Participants]
     
Female   21   30   51 
Male   11   37   48 
Region of Enrollment 
[Units: Participants]
     
United States   32   67   99 


  Outcome Measures
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1.  Primary:   hCAP18 Levels   [ Time Frame: Baseline ]

2.  Primary:   Baseline 25-OH Vitamin D Level   [ Time Frame: Baseline ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: Massachusetts General Hospital
phone: 617-726-3934
e-mail: ibhan@partners.org



Responsible Party: Ishir Bhan, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00742235     History of Changes
Other Study ID Numbers: 2008-P-0003000/1
First Submitted: August 25, 2008
First Posted: August 27, 2008
Results First Submitted: June 5, 2013
Results First Posted: November 11, 2013
Last Update Posted: April 14, 2016