drugset / Trial / NCT02197286
Targeted Vitamin D Treatment of Schizophrenia-Associated Hyperprolinemia
Phase 2
Withdrawn
NYU Langone Health
Columbia University · collabStanley Medical Research Institute · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2015-02
- Primary completion
- 2017-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 4000 iu | Oral |