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NCT02281162 · ClinicalTrials.gov registry record
The Influence of Vitamin D on Atypical Antipsychotic-induced Weight Gain
A clinical trial, sponsored by Creighton University.
- Completed
- Registry status
- 20
- Enrollment target
NCT02281162 is a clinical trial that has completed, run by Creighton University. The registered enrollment target is 20 participants.
The verdict
NCT02281162 has completed, sponsored by Creighton University.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study 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.
Interventions
- OTHER Blood Draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-11 |
| Est. Completion | 2015-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02281162
The ClinicalTrials.gov registry entry for NCT02281162 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Creighton University, which has 98 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Blood Draw is the first listed.
NCT02281162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02281162 about?
NCT02281162 is a clinical study titled "The Influence of Vitamin D on Atypical Antipsychotic-induced Weight Gain". 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 gai...
What is the current status of trial NCT02281162?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2014-11. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02281162?
The interventions under investigation include: Blood Draw (OTHER).
Who is sponsoring clinical trial NCT02281162?
This trial is sponsored by Creighton University, which has 98 total clinical trials registered on ClinicalTrials.gov.
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