SchizophreniaPhase 4NCT01169142
Study of Vitamin D in the Severely Mentally Ill
A Phase 4 study testing Vitamin D3 in people with Schizophrenia and Schizoaffective Disorder, run by Bronx Psychiatric Center at 1 site in United States.
Trial summary
Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-70,
- Schizophrenia or Schizoaffective disorder
- stabilized but not expecting to be discharged soon
- capacity to give informed consent
Who cannot join
- acutely psychotic
- acutely medically ill
- renal insufficiency
- hypercalcemia
- hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients
Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures.
Read the detailed description
Subjects with levels of Vitamin D between 7ng/ml and 30ng/ml will, after signing consent forms, be randomly assigned to either start immediately on Vitamin D for three months or to start after a delay of three months. Those with levels below 7gn/ml will start immediately. All will be evaluated monthly with blood tests, PANSS, movement disorder ratings and information on health and progress from the clinical chart.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Vitamin D3
- Keywords
- Vitamin D, Schizophrenia, Severely Mentally Ill
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
50,000 units of Vitamin D3 weekly
Vitamin D3Dietary supplement
Also called Cholecalciferol
Vitamin D3 50,000 units weekly
| Study group | Role | What they receive |
|---|---|---|
| Immediate Vitamin D3 | Active comparator | Will start Vitamin D3 immediately Receives: Dietary Supplement: Vitamin D3 |
| Three month delay | Active comparator | Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately) Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychopathology as measured by the PANSS
PANSS is being done every month
Measured: 3 months
Secondary outcomes (2)
movement disorder
AIMS (for tardive dyskinesia), Simpson-Angus (for Parkinsonism) and Barnes (for Akathisia) movement disorder rating scales will be completed monthly.
Measured: three months
General Health
Measured by staff observation and reports, Labs for example glucose mg/dL, HgbA1c %A1c, Vitamin D ng/ml, calcium mg/dL, assessed monthly
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bronx Psychiatric Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nigel Bark MD, Bronx Psychiatric Center
- Investigators
- NIgel Bark, MD, Principal investigator, Bronx Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169142
- Sponsor's protocol ID
- BPCIRB0804
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2010
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients
- ClinicalTrials.gov ID
- NCT01169142
- Acronym / sponsor ID
- BPCIRB0804
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Vitamin D, Schizophrenia, Severely Mentally Ill
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bronx Psychiatric CenterOther government
- Study start
- Jan 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures.
Detailed description
Subjects with levels of Vitamin D between 7ng/ml and 30ng/ml will, after signing consent forms, be randomly assigned to either start immediately on Vitamin D for three months or to start after a delay of three months. Those with levels below 7gn/ml will start immediately. All will be evaluated monthly with blood tests, PANSS, movement disorder ratings and information on health and progress from the clinical chart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D3Will start Vitamin D3 immediately |
| Three month delay | Active comparator | Dietary Supplement: Vitamin D3Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 19-70,
- Schizophrenia or Schizoaffective disorder
- stabilized but not expecting to be discharged soon
- capacity to give informed consent
Key exclusion criteria (5 listed)
- acutely psychotic
- acutely medically ill
- renal insufficiency
- hypercalcemia
- hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: Cholecalciferol50,000 units of Vitamin D3 weekly | Dietary supplement | Three month delay |
| Vitamin D3Also: CholecalciferolVitamin D3 50,000 units weekly | Dietary supplement | Immediate Vitamin D3 |
Primary outcome
Psychopathology as measured by the PANSS
Time frame: 3 months
PANSS is being done every month
2 secondary outcomes
movement disorder
Time frame: three months
General Health
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NIgel Bark, MD principal investigator
Bronx Psychiatric Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 in people with Schizophrenia and Schizoaffective Disorder, run by Bronx Psychiatric Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychopathology as measured by the PANSS (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.