Vitamin D Supplementation in Psychiatric Illnesses (VDSS)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Schizophrenia; Schizoaffective Disorder; Vitamin D Deficiency; Psychosis
• Intervention / Treatment: Drug: Ergocalciferols

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D	Drug: Ergocalciferols; 2000 international units by mouth daily for 8 weeks.; Other Names: Drisdol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Weight	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in Serum Levels of C-reactive Protein.		Baseline and 8 weeks
HDL-cholesterol at Baseline and Post-treatment		Baseline and 8 weeks
LDL-cholesterol at Baseline and Post-treatment		Baseline and 8 weeks
Total Cholesterol at Baseline and Post-treatment		Baseline and 8 weeks
Triglycerides at Baseline and Post-treatment		Baseline and 8 weeks
Adiponectin at Baseline and Post-treatment		Baseline and 8 weeks
Leptin at Baseline and Post-treatment		Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: Benjamin U Nwosu, MD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: October 28, 2009
• First Submitted That Met QC Criteria: October 28, 2009
• First Posted (Estimate): October 29, 2009

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Vitamin D deficiency; Psychiatric illnesses
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Schizophrenia; Psychotic Disorders; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Ergocalciferols
• Other Study ID Numbers: Docket #13212