Targeted Vitamin D Treatment of Schizophrenia-Associated Hyperprolinemia

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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 proline. The aims of the study are to evaluate an anticipated clinical response to vitamin D supplementation including negative symptoms and cognitive deficits, evaluate safety of vitamin D supplementation for schizophrenia patients and evaluate the relationship of changes in plasma proline levels and efficacy outcomes.

Key facts

Study ID

NCT02197286

Run by

NYU Langone Health

People needed

0

Starts

2015-02-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Bellevue Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

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