Clinical trial NCT01004354: Vitamin D Supplementation in Psychiatric Illnesses
Official title: Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Vitamin D Deficiency
Psychosis
Schizophrenia
Schizoaffective Disorder
Keywords: Psychiatric illnesses
Vitamin D deficiency
Obesity
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment
timeFrame: Baseline and 8 weeks
measure: Changes in Serum Levels of C-reactive Protein.
timeFrame: Baseline and 8 weeks
measure: HDL-cholesterol at Baseline and Post-treatment
timeFrame: Baseline and 8 weeks
measure: LDL-cholesterol at Baseline and Post-treatment
timeFrame: Baseline and 8 weeks
measure: Total Cholesterol at Baseline and Post-treatment
timeFrame: Baseline and 8 weeks
measure: Triglycerides at Baseline and Post-treatment
timeFrame: Baseline and 8 weeks
measure: Adiponectin at Baseline and Post-treatment
timeFrame: Baseline and 8 weeks
measure: Leptin at Baseline and Post-treatment
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Benjamin U Nwosu, MD
role: PRINCIPAL_INVESTIGATOR
References: