Vitamin D Supplementation in Psychiatric Illnesses (VDSS)
This study has been completed.
Sponsor:
University of Massachusetts, Worcester
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
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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
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
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
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
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
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. |
Results Point of Contact:
Name/Title: Benjamin U Nwosu, MD
Organization: University of Massachusetts Medical School
phone: 5083347872
e-mail: benjamin.nwosu@umassmemorial.org
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 |