Targeted Vitamin D Treatment of Schizophrenia-Associated Hyperprolinemia

NCT02197286 | Withdrawn Phase 2

• 1 other identifier: S13-01127
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Clinical response to supplementation with vitamin D.

  To evaluate an anticipated clinical response to supplementation with vitamin D including negative symptoms and cognitive deficits by the change in the Positive and Negative Symptom Scale (PANSS) total score and the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive scale. Secondary outcomes will also involve investigation of individual domains of the PANSS and MATRICS.

  Baseline (start of vitamin D supplementation) through ten weeks of treatment.

Secondary Outcomes (1)

• Biological response to supplementation with vitamin D.

  Lead-in phase visit, baseline visit and then at biweekly visits through ten weeks of treatment.

Other Outcomes (5)

• Length of hospital stay.

  Lead-in phase visit, baseline visit and then at biweekly visits until discharge, an expected average period from lead-in to discharge of seven weeks.

• Number of participants with adverse events as a measure of safety.

  Throughout 10 week treatment study period.

• Clinical response to supplementation with vitamin D.

  Baseline (start of vitamin D supplementation) through ten weeks of treatment.

Study Arms (2)

Vitamin D (cholecalciferol)

EXPERIMENTAL

Intervention: Capsules containing the active ingredient, cholecalciferol @ 4,000 international units (IU). One capsule daily, oral administration for 10 weeks.

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

Daily matching placebo gelatin capsule (also contains microcrystalline cellulose). Capsules are identical in size, color and taste to experimental drug.

Drug: Placebo

Interventions

Cholecalciferol DRUG

One capsule containing 4,000 IU of Cholecalciferol, per day

Also known as: Other name: Vitamin D3, Trade name:Biotech Pharmacal, Inc: Vitamin D3-4,, 4,000 IU per day

Vitamin D (cholecalciferol)

Placebo DRUG

Daily dose of a single gelatin placebo capsule.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• (OH)D insufficiency (\<30ng/ml).
• Confirmed diagnosis of schizophreniform disorder, schizophrenia or schizoaffective disorder.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• NYU Langone Health: lead
• Stanley Medical Research Institute: collaborator
• Columbia University: collaborator

Study Sites (1)

Bellevue Hospital Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• James D Clelland

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 22, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

US (1)