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Vitamin D Supplementation in Psychiatric Illnesses (VDSS)

Primary Purpose

Obesity, Vitamin D Deficiency, Psychosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferols
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Psychiatric illnesses, Vitamin D deficiency, Obesity

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males/females between the ages 10 through 18 years,
  2. Subjects with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)[62] Axis 1 diagnosis who are on treatment with SGA. These conditions include schizophrenia, schizo-affective disorder, and psychosis,
  3. Subjects who have gained 10% of their pre-drug body weight while receiving the following SGAs: risperidone, aripiprazole, clozapine, quetiapine and olanzapine. Subjects could be taking other psychotropic agents, but only one SGA,
  4. All subjects will be able to take the prescribed vitamin D by mouth,
  5. All subjects will have a 25-hydroxyvitamin D level of < 32 ng/mL,
  6. All subjects must reside in an in-patient psychiatric facility.

Exclusion Criteria:

  1. Pregnant or lactating women,
  2. Patients with mental retardation (intelligence quotient < 50),
  3. Subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases,
  4. Subjects with known history of parathyroid disorder,
  5. Subjects with acquired or congenital disorders of vitamin D metabolism,
  6. Subjects on calcium and vitamin D replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol,
  7. Subjects taking any weight loss medications, such as orlistat, and sibutramine,
  8. Subjects on medications that might affect glucose levels, such as insulin or metformin.

Sites / Locations

  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D

Arm Description

Outcomes

Primary Outcome Measures

Change in Weight

Secondary Outcome Measures

Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment
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
Changes in Serum Levels of C-reactive Protein.
HDL-cholesterol at Baseline and Post-treatment
LDL-cholesterol at Baseline and Post-treatment
Total Cholesterol at Baseline and Post-treatment
Triglycerides at Baseline and Post-treatment
Adiponectin at Baseline and Post-treatment
Leptin at Baseline and Post-treatment

Full Information

First Posted
October 28, 2009
Last Updated
November 1, 2017
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT01004354
Brief Title
Vitamin D Supplementation in Psychiatric Illnesses
Acronym
VDSS
Official Title
Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Vitamin D Deficiency, Psychosis, Schizophrenia, Schizoaffective Disorder
Keywords
Psychiatric illnesses, Vitamin D deficiency, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ergocalciferols
Other Intervention Name(s)
Drisdol
Intervention Description
2000 international units by mouth daily for 8 weeks.
Primary Outcome Measure Information:
Title
Change in Weight
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment
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
Title
Changes in Serum Levels of C-reactive Protein.
Time Frame
Baseline and 8 weeks
Title
HDL-cholesterol at Baseline and Post-treatment
Time Frame
Baseline and 8 weeks
Title
LDL-cholesterol at Baseline and Post-treatment
Time Frame
Baseline and 8 weeks
Title
Total Cholesterol at Baseline and Post-treatment
Time Frame
Baseline and 8 weeks
Title
Triglycerides at Baseline and Post-treatment
Time Frame
Baseline and 8 weeks
Title
Adiponectin at Baseline and Post-treatment
Time Frame
Baseline and 8 weeks
Title
Leptin at Baseline and Post-treatment
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males/females between the ages 10 through 18 years, Subjects with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)[62] Axis 1 diagnosis who are on treatment with SGA. These conditions include schizophrenia, schizo-affective disorder, and psychosis, Subjects who have gained 10% of their pre-drug body weight while receiving the following SGAs: risperidone, aripiprazole, clozapine, quetiapine and olanzapine. Subjects could be taking other psychotropic agents, but only one SGA, All subjects will be able to take the prescribed vitamin D by mouth, All subjects will have a 25-hydroxyvitamin D level of < 32 ng/mL, All subjects must reside in an in-patient psychiatric facility. Exclusion Criteria: Pregnant or lactating women, Patients with mental retardation (intelligence quotient < 50), Subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases, Subjects with known history of parathyroid disorder, Subjects with acquired or congenital disorders of vitamin D metabolism, Subjects on calcium and vitamin D replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol, Subjects taking any weight loss medications, such as orlistat, and sibutramine, Subjects on medications that might affect glucose levels, such as insulin or metformin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin U Nwosu, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

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Vitamin D Supplementation in Psychiatric Illnesses

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