Status:
WITHDRAWN
Targeted Vitamin D Treatment of Schizophrenia-Associated Hyperprolinemia
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Stanley Medical Research Institute
Columbia University
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A ten week, blinded trial of vitamin D vs. placebo in 80 patients with schizophrenia or schizoaffective disorder who have low blood levels of vitamin D and elevated blood levels of the amino acid prol...
Detailed Description
25-hydroxyvitamin D (vitD) insufficiency is associated with cognitive decline and has long-been considered important in schizophrenia susceptibility. VitD supplementation has been suggested for those ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Recruitment
- Male and Female, all racial/ethnic groups, aged 18-65 years.
- Admission diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
- Capability to give informed consent.
- Inclusion Criteria for Randomization and Trial Entry
- Fasting hyperprolinemia (defined as 2 standard deviations (SDs) above the gender-adjusted mean measured for historical controls: 203.3 micromolar (uM) for females and 327.6 uM for males).
- 25(OH)D insufficiency (\<30ng/ml).
- Confirmed diagnosis of schizophreniform disorder, schizophrenia or schizoaffective disorder.
Exclusion
- Exclusion Criteria for Recruitment
- Organic brain disorders.
- Valproate treatment within 14 days, because of known proline up-regulatory effects.
- Pregnant women or women of child-bearing potential, who are not surgically-sterile or who are not using appropriate methods of birth control.
- Amino acid metabolism disorder diagnosis.
- Hypercalcemia (\>10.4mg/dL), hypercalciuria (\>0.20mg/mg), hyperthyroidism (\>65pg/ml) or history of renal stones, kidney disease, atherosclerosis, sarcoidosis, histoplasmosis and lymphoma.
- Chart record of HIV positive status.
- Treatment with clozapine, as this may reflect general treatment resistance.
- Exclusion Criteria for Randomization and Trial Entry
- Abnormal serum/ urine metabolic lab values suggesting hypercalcemia (serum Calcium \>10.4mg/dL), hypercalciuria (urine calcium/urine creatinine \>0.20 mg/mg), or hyperthyroidism (parathyroid hormone (PTH) \> 65pg/ml).
- Initiation of Valproate treatment.
- Continued use of dietary supplementation, such as fish oil supplementation or vitamin D supplements (\>400 IU/day).
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02197286
Start Date
February 1 2015
Last Update
October 12 2015
Active Locations (1)
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1
Bellevue Hospital Center
New York, New York, United States, 10016