Vitamin D Supplementation in Psychiatric Illnesses

Obesity Clinical Trial

— VDSS  

Official title:

Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004354
• Other study ID #: Docket #13212
• Status: Completed
• Phase: N/A
• First received: October 28, 2009
• Last updated: November 1, 2017
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: November 2017
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Obesity
• Psychosis
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Vitamin D Deficiency

Intervention

Drug:
• Ergocalciferols
2000 international units by mouth daily for 8 weeks.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight		Baseline and 8 weeks
Secondary	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	Baseline and 8 weeks
Secondary	Changes in Serum Levels of C-reactive Protein.		Baseline and 8 weeks
Secondary	HDL-cholesterol at Baseline and Post-treatment		Baseline and 8 weeks
Secondary	LDL-cholesterol at Baseline and Post-treatment		Baseline and 8 weeks
Secondary	Total Cholesterol at Baseline and Post-treatment		Baseline and 8 weeks
Secondary	Triglycerides at Baseline and Post-treatment		Baseline and 8 weeks
Secondary	Adiponectin at Baseline and Post-treatment		Baseline and 8 weeks
Secondary	Leptin at Baseline and Post-treatment		Baseline and 8 weeks