Vitamin D Supplementation in Psychiatric Illnesses

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01004354

Acronym

VDSS

Enrollment

Registered

2009-10-29

Start date

2009-06-30

Completion date

2010-06-30

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Psychosis, Schizoaffective Disorder, Schizophrenia, Vitamin D Deficiency

Keywords

Psychiatric illnesses, Vitamin D deficiency, Obesity

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.

Interventions

DRUGErgocalciferols

2000 international units by mouth daily for 8 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

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.

Design outcomes

Primary

Measure	Time frame
Change in Weight	Baseline and 8 weeks

Secondary

Measure	Time frame	Description
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	—
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
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	—
Total Cholesterol at Baseline and Post-treatment	Baseline and 8 weeks	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Vitamin D This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.	12
Total	12

Baseline characteristics

Characteristic	Vitamin D
Age, Categorical <=18 years	12 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants
Age, Continuous	16.6 years STANDARD_DEVIATION 1.65
Region of Enrollment United States	12 participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 12
serious Total, serious adverse events	0 / 12