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Vitamin D Deficiency, Insulin Resistance and FGF-23

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ClinicalTrials.gov Identifier: NCT00491322
Recruitment Status : Completed
First Posted : June 26, 2007
Results First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Sherri-Ann M. Burnett-Bowie, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Vitamin D Deficiency
Interventions: Dietary Supplement: Ergocalciferol
Dietary Supplement: Ergocalciferol placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from 2006-2008. Subjects were healthy volunteers recruited from the community

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ergocalciferol Group Ergocalciferol 50000 international units once a week for 12 weeks
Placebo Group Matching placebo once a week for 12 weeks

Participant Flow:   Overall Study
    Ergocalciferol Group   Placebo Group
STARTED   41   51 
COMPLETED   40   50 
NOT COMPLETED   1   1 
Protocol Violation                1                0 
Pregnancy                0                1 



  Baseline Characteristics

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.
While 92 subjects were enrolled, 2 subjects, 1 in each group, were withdrawn from the study and their data never analyzed due to pregnancy that prevented initiation of the study drug and 6 week non-compliance with the study medication due to a non-related illness.

Reporting Groups
  Description
Ergocalciferol Group Ergocalciferol 50000 international units once a week for 12 weeks
Placebo Group Matching placebo once a week for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Ergocalciferol Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   50   90 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      40 100.0%      50 100.0%      90 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 28  (7)   29  (9)   28  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  60.0%      31  62.0%      55  61.1% 
Male      16  40.0%      19  38.0%      35  38.9% 
Region of Enrollment 
[Units: Participants]
     
United States   40   50   90 


  Outcome Measures

1.  Primary:   Fibroblast Growth Factor 23 (FGF23) After 12 Weeks of Weekly Ergocalciferol 50000 Units   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Dr. Sherri-Ann M. Burnett-Bowie
Organization: Massachusetts General Hospital
phone: 6177245594
e-mail: sburnett-bowie@mgh.harvard.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sherri-Ann M. Burnett-Bowie, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00491322     History of Changes
Other Study ID Numbers: 2006-P-000430/18
K23DK073356 ( U.S. NIH Grant/Contract )
First Submitted: June 22, 2007
First Posted: June 26, 2007
Results First Submitted: October 25, 2013
Results First Posted: May 2, 2018
Last Update Posted: May 2, 2018