Vitamin D Supplementation in Psychiatric Illnesses (VDSS)
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| Tracking Information | |||||
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| First Received Date ICMJE | October 28, 2009 | ||||
| Last Updated Date | January 10, 2012 | ||||
| Start Date ICMJE | June 2009 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Weight [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Changes in waist circumference. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01004354 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vitamin D Supplementation in Psychiatric Illnesses | ||||
| Official Title ICMJE | Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents | ||||
| Brief Summary | Children and adolescents with psychiatric illnesses who are treated with medications called second generation antipsychotic agents (SGA) often gain excessive weight during their treatment with these medications. This weight gain may result in the development of features of the metabolic syndrome or frank diabetes mellitus. There is no consensus on the best way to prevent these complications. The investigators' hypothesis is that daily vitamin D supplementation in these patients will result in decreased levels of the markers of metabolic syndrome with associated reduction in waist circumference. |
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| Detailed Description | In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Ergocalciferols
2000 international units by mouth daily for 8 weeks.
Other Name: Drisdol |
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| Study Arm (s) | Experimental: Vitamin D
Intervention: Drug: Ergocalciferols |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 12 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 10 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01004354 | ||||
| Other Study ID Numbers ICMJE | Docket #13212 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Benjamin U. Nwosu, University of Massachusetts, Worcester | ||||
| Study Sponsor ICMJE | University of Massachusetts, Worcester | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Massachusetts, Worcester | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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