The Influence of Vitamin D on Atypical Antipsychotic-induced Weight Gain

NCT02281162 | Completed

• 1 other identifier: 632260-2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Schizophrenia and bipolar disorders are major public health problems. The second generation anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable risk profile as far as movement disorders. However, these drugs are associated with clinically significant weight gain and metabolic effects. The underlying mechanisms of these side effects are unclear, however in our preliminary studies with schizophrenic patients on atypical anti-psychotic drugs, we found that weight gain and vitamin D deficiency was present in about 50% of this population. Given the considerable heterogeneity among the patients on atypical anti-psychotics and potential for weight gain in vitamin D-deficient states, we propose that patients with schizophrenia who gain weight on atypical antipsychotic medications are vitamin D-deficient. This hypothesis will be tested in patients with schizophrenia receiving second-generation anti-psychotic drugs for a minimum duration of 4 months. Specific Aim: We predict that the patients with schizophrenia, who gain weight with antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain weight. We will examine circulating levels of serum 25(OH)D, mRNA transcripts and protein expression of vitamin D receptor (VDR) and the enzymes, CYP24A and CYP27B, in the white blood cells of the subjects and correlate with BMI and the blood levels of leptin and adiponectin.

Conditions

Schizophrenia; Metabolic Syndrome; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Weight Gain in Chart or Graph

  We expect about 50% patients on anti-psychotic medication will gain weight and these patients will be vitamin D-deficient with \<30 ng/ml serum 25(OH)D level.

  less than 12 months

Study Arms (2)

Weight Gain

No intervention. Will evaluate vitamin D levels and other biomarkers affecting weight with venous blood draw.

Other: Blood Draw

No Weight Gain

No intervention. Will evaluate vitamin D levels and other biomarkers affecting weight with venous blood draw.

Other: Blood Draw

Interventions

Blood Draw OTHER

Blood Draw

No Weight Gain; Weight Gain

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

approximately 40 subjects with schizophrenia, bipolar disorder, and schizoaffective disorder, both male and female, 21-65 years, of all ethnicities will be recruited.

You may qualify if:

• Men and women with a DSM-IV clinical diagnosis of Schizophrenia, Schizoaffective or Bipolar disorder
• to 65 years of age; male and female
• A willingness and ability to provide signed informed consent
• The subject should have been on quetiapine 100 mg or more for more than 12 weeks.

You may not qualify if:

• Pregnant women
• Subjects considered at high suicide risk based on the MINI Suicidality Module (\> 17 points)
• Unstable general medical condition or serious illness (e.g. death or hospitalization is anticipated within one year), poor kidney function or liver function (defined as laboratory values ≥ three times the upper limit of the normal), and seizure disorders except for childhood seizure disorders
• Concurrent therapy with certain psychotropics is permitted, provided that the medication and dose have been stable for the past 90 days
• Patients on concomitant treatment with clozapine and olanzapine are not permitted.
• Patients on immunosuppressant medications or any orexigenic or anorexigenic drug
• Patients on concomitant treatment with amphetamines and/ or methylphenidate
• History of hypothyroidism or thyroxine therapy
• Patients with a known condition or undergoing therapeutic measures that affects weight, including but not limited to: eating disorder, type I diabetes, hyperthyroidism, thyroxine therapy, Topamax therapy, and infectious diseases, such as HIV, hepatitis B, and hepatitis C
• Active supplementation of vitamin D within the last 3 months

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Alegent Creighton Clinic - Psychiatric Associates (Dodge Street)

Omaha, Nebraska, 68132, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

40 ml venous blood will be collected in three separate tubes. One tube of 10 ml will be sent to the Clinical Pathology Labs for the measurement of complete blood count, complete metabolic panel, fasting lipid profile for the measurement of triglycerides, high density lipoproteins, low density lipoproteins, very low-density lipoproteins. The complete blood count and complete metabolic panel will be done to rule out infection or any other co-morbidity. Another 10 ml tube will be sent to Clinical Pathology lab for the measurement of serum 25-hydroxy D levels. The third tube with 20 ml blood will be used to measure protein and mRNA expression of vitamin D receptor (VDR), CYP24A1 and CYP27B1, and to measure leptin and adiponectin levels.

MeSH Terms

Conditions

Schizophrenia; Metabolic Syndrome; Vitamin D Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Vithyalakshmi Selvaraj, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: November 3, 2014
• Study Start: November 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

US (1)