Vitamin D Supplementation in Psychiatric Illnesses (VDSS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin U. Nwosu, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01004354
First received: October 28, 2009
Last updated: January 10, 2012
Last verified: January 2012
Results First Received: October 17, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     12  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  16.6  ± 1.65  
Gender  
[units: participants]
 
Female     4  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures

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

2.  Secondary:   Changes in the Baseline and Post-treatment Values of the Markers of the Metabolic Syndrome (Insulin, C-peptide, Fasting Blood Glucose, Homeostasis Model of Insulin Resistance (HOMA-IR), High Density Lipoprotein Cholesterol).   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Changes in Serum Levels of Adiponectin, Leptin, and C-reactive Protein.   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   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: Benjamin U Nwosu, MD
Organization: University of Massachusetts Medical School
phone: 5083347872
e-mail: benjamin.nwosu@umassmemorial.org


No publications provided


Responsible Party: Benjamin U. Nwosu, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01004354     History of Changes
Other Study ID Numbers: Docket #13212
Study First Received: October 28, 2009
Results First Received: October 17, 2011
Last Updated: January 10, 2012
Health Authority: United States: Institutional Review Board