Targeted Vitamin D Treatment of Schizophrenia-Associated Hyperprolinemia

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: Columbia University; Stanley Medical Research Institute
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

Inclusion Criteria for Recruitment

1. Male and Female, all racial/ethnic groups, aged 18-65 years.

2. Admission diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.

3. Capability to give informed consent.

Inclusion Criteria for Randomization and Trial Entry

1. 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).

2. 25(OH)D insufficiency (<30ng/ml).

3. Confirmed diagnosis of schizophreniform disorder, schizophrenia or schizoaffective disorder.

Exclusion Criteria:

Exclusion Criteria for Recruitment

1. Organic brain disorders.

2. Valproate treatment within 14 days, because of known proline up-regulatory effects.

3. Pregnant women or women of child-bearing potential, who are not surgically-sterile or who are not using appropriate methods of birth control.

4. Amino acid metabolism disorder diagnosis.

5. Hypercalcemia (>10.4mg/dL), hypercalciuria (>0.20mg/mg), hyperthyroidism (>65pg/ml) or history of renal stones, kidney disease, atherosclerosis, sarcoidosis, histoplasmosis and lymphoma.

6. Chart record of HIV positive status.

7. Treatment with clozapine, as this may reflect general treatment resistance.

Exclusion Criteria for Randomization and Trial Entry

1. 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).

2. Initiation of Valproate treatment.

3. Continued use of dietary supplementation, such as fish oil supplementation or vitamin D supplements (>400 IU/day).