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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02281162
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
Creighton University

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.

Condition or disease Intervention/treatment
Schizophrenia Metabolic Syndrome Vitamin D Deficiency Other: Blood Draw

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Role of Vitamin D and Quetiapine-induced Weight Gain
Study Start Date : November 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
Weight Gain
No intervention. Will evaluate vitamin D levels and other biomarkers affecting weight with venous blood draw.
Other: Blood Draw
Blood Draw

No Weight Gain
No intervention. Will evaluate vitamin D levels and other biomarkers affecting weight with venous blood draw.
Other: Blood Draw
Blood Draw

Primary Outcome Measures :
  1. Number of Patients With Weight Gain in Chart or Graph [ Time Frame: less than 12 months ]
    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.

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

  • • Men and women with a DSM-IV clinical diagnosis of Schizophrenia, Schizoaffective or Bipolar disorder

    • 21 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.

Exclusion Criteria:

  1. Pregnant women
  2. Subjects considered at high suicide risk based on the MINI Suicidality Module (> 17 points)
  3. 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
  4. Concurrent therapy with certain psychotropics is permitted, provided that the medication and dose have been stable for the past 90 days
  5. Patients on concomitant treatment with clozapine and olanzapine are not permitted.
  6. Patients on immunosuppressant medications or any orexigenic or anorexigenic drug
  7. Patients on concomitant treatment with amphetamines and/ or methylphenidate
  8. History of hypothyroidism or thyroxine therapy
  9. 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
  10. Active supplementation of vitamin D within the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02281162

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United States, Nebraska
Alegent Creighton Clinic - Psychiatric Associates (Dodge Street)
Omaha, Nebraska, United States, 68132
Sponsors and Collaborators
Creighton University
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Principal Investigator: Vithyalakshmi Selvaraj, MD Creighton University
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Responsible Party: Creighton University Identifier: NCT02281162    
Other Study ID Numbers: 632260-2
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Metabolic Syndrome
Vitamin D Deficiency
Weight Gain
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Deficiency Diseases
Nutrition Disorders
Body Weight Changes
Body Weight
Signs and Symptoms