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Vitamin D Supplementation in Psychiatric Illnesses (VDSS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004354
First Posted: October 29, 2009
Last Update Posted: November 6, 2017
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):
Benjamin U. Nwosu, University of Massachusetts, Worcester
Results First Submitted: October 17, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Obesity
Vitamin D Deficiency
Psychosis
Schizophrenia
Schizoaffective Disorder
Intervention: Drug: Ergocalciferols

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vitamin D This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.

Participant Flow:   Overall Study
    Vitamin D
STARTED   12 
COMPLETED   12 
NOT COMPLETED   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.
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Reporting Groups
  Description
Vitamin D This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.

Baseline Measures
   Vitamin D 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      12 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 16.6  (1.65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  33.3% 
Male      8  66.7% 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Weight   [ Time Frame: Baseline and 8 weeks ]

2.  Secondary:   Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment   [ Time Frame: Baseline and 8 weeks ]

3.  Secondary:   Changes in Serum Levels of C-reactive Protein.   [ Time Frame: Baseline and 8 weeks ]

4.  Secondary:   HDL-cholesterol at Baseline and Post-treatment   [ Time Frame: Baseline and 8 weeks ]

5.  Secondary:   LDL-cholesterol at Baseline and Post-treatment   [ Time Frame: Baseline and 8 weeks ]

6.  Secondary:   Total Cholesterol at Baseline and Post-treatment   [ Time Frame: Baseline and 8 weeks ]

7.  Secondary:   Triglycerides at Baseline and Post-treatment   [ Time Frame: Baseline and 8 weeks ]

8.  Secondary:   Adiponectin at Baseline and Post-treatment   [ Time Frame: Baseline and 8 weeks ]

9.  Secondary:   Leptin at Baseline and Post-treatment   [ Time Frame: Baseline and 8 weeks ]


  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: Benjamin U Nwosu, MD
Organization: University of Massachusetts Medical School
phone: 5083347872
e-mail: benjamin.nwosu@umassmemorial.org



Responsible Party: Benjamin U. Nwosu, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01004354     History of Changes
Other Study ID Numbers: Docket #13212
First Submitted: October 28, 2009
First Posted: October 29, 2009
Results First Submitted: October 17, 2011
Results First Posted: February 10, 2012
Last Update Posted: November 6, 2017