Vitamin D Supplementation in Psychiatric Illnesses

Not Applicable

Completed

• Conditions: Psychosis; Obesity; Schizophrenia; Schizoaffective Disorder; Vitamin D Deficiency
• Interventions: Drug: Ergocalciferols

• Registration Number: NCT01004354
• Lead Sponsor: University of Massachusetts, Worcester

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-10-28
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-10-17
• Results First Submitted QC: 2012-01-10
• Results First Posted: 2012-02-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D	Ergocalciferols	-

Primary Outcome Measures

Name	Time	Method
Change in Weight	Baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in Serum Levels of C-reactive Protein.	Baseline and 8 weeks
HDL-cholesterol at Baseline and Post-treatment	Baseline and 8 weeks
Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment	Baseline and 8 weeks	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
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

Trial Locations

Locations (1)

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States