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hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ishir Bhan, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00742235
First received: August 25, 2008
Last updated: September 9, 2013
Last verified: September 2013
Results First Received: June 5, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: 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     40  
NOT COMPLETED     0     27  
Lost to Follow-up                 0                 27  



  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  
Number of Participants  
[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

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

2.  Primary:   hCAP18 Levels   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   12/2013   Safety Issue:   No


  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


No publications provided


Responsible Party: Ishir Bhan, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00742235     History of Changes
Other Study ID Numbers: 2008-P-0003000/1
Study First Received: August 25, 2008
Results First Received: June 5, 2013
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board