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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT02281162
First received: September 25, 2014
Last updated: January 7, 2016
Last verified: January 2016
  Purpose
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 Intervention
Schizophrenia Metabolic Syndrome Vitamin D Deficiency Other: Blood Draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Role of Vitamin D and Quetiapine-induced Weight Gain

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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.

Enrollment: 20
Study Start Date: November 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (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.
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02281162

Locations
United States, Nebraska
Alegent Creighton Clinic - Psychiatric Associates (Dodge Street)
Omaha, Nebraska, United States, 68132
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Vithyalakshmi Selvaraj, MD Creighton University
  More Information

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT02281162     History of Changes
Other Study ID Numbers: 632260-2
Study First Received: September 25, 2014
Last Updated: January 7, 2016

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Vitamin D Deficiency
Weight Gain
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 21, 2017