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Vitamin D Supplementation in Psychiatric Illnesses (VDSS)

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ClinicalTrials.gov Identifier: NCT01004354
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : February 10, 2012
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Benjamin U. Nwosu, University of Massachusetts, Worcester

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
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vitamin D
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Vitamin D
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
12
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
16.6  (1.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Change in Weight
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: kilograms
0.07  (0.06)
2.Secondary Outcome
Title Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment
Hide Description

HOMA-IR:

It is calculated multiplying fasting plasma insulin (FPI) by fasting plasma glucose (FPG), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5

Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: HOMA-IR score
Baseline 3.01  (2.65)
Final (8 weeks) 2.48  (2.00)
3.Secondary Outcome
Title Changes in Serum Levels of C-reactive Protein.
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected for this analyte.
Arm/Group Title Vitamin D
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title HDL-cholesterol at Baseline and Post-treatment
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 43.4  (8.75)
Final (8 weeks) 39.8  (9.35)
5.Secondary Outcome
Title LDL-cholesterol at Baseline and Post-treatment
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 102.00  (23.17)
Final (8 weeks) 86.89  (29.60)
6.Secondary Outcome
Title Total Cholesterol at Baseline and Post-treatment
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 173.67  (21.22)
Final (8 weeks) 161.33  (20.35)
7.Secondary Outcome
Title Triglycerides at Baseline and Post-treatment
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 189.7  (176.8)
Final (8 weeks) 197.9  (121.31)
8.Secondary Outcome
Title Adiponectin at Baseline and Post-treatment
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Baseline 9.1  (4.75)
Final (8 weeks) 8.9  (4.7)
9.Secondary Outcome
Title Leptin at Baseline and Post-treatment
Hide Description [Not Specified]
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 39.23  (22.54)
Final (8 weeks) 43.69  (24.37)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin D
Hide Arm/Group Description 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.
All-Cause Mortality
Vitamin D
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vitamin D
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vitamin D
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Benjamin U Nwosu, MD
Organization: University of Massachusetts Medical School
Phone: 5083347872
EMail: benjamin.nwosu@umassmemorial.org
Layout table for additonal information
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