SchizophreniaPhase 3NCT03284294
Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia
A Phase 3 study testing Cholecalciferol in people with Schizophrenia, run by Universitas Padjadjaran.
Trial summary
The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2020to Dec 2020
- Phase
- Phase 3
- 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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Chronic schizophrenia
- Serum 25(OH)D level below 30 ng/ml
- Deficit in cognitive functions
Who cannot join
- Hypercalcemia
- Hepatic or renal failure
- Obese
- Metabolic syndrome
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic
The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive function will be performed at baseline and after 8 weeks period.
- Conditions
- Schizophrenia
- Being tested
- Cholecalciferol, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
cholecalciferol 2000 IU oral daily for 8 weeks
PlaceboDrug
Oral placebo daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral placebo daily for 8 weeks Receives: Drug: Placebo |
| Vitamin D | Active comparator | Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
cognitive function as measured with standard cognitive battery
Measured: At the end of week 8
Secondary outcomes (1)
BDNF serum level
BDNF serum level as measured with ELISA method
Measured: At the end of week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start15 Apr 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuti Kurnianingsih, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284294
- Sponsor's protocol ID
- PS-201709.01
- Status last verified
- Mar 2020
- First submitted
- 4 Sep 2017
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic
- ClinicalTrials.gov ID
- NCT03284294
- Acronym / sponsor ID
- PS-201709.01
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Sep 2017 (actual)
- 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.
The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive function will be performed at baseline and after 8 weeks period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOral placebo daily for 8 weeks |
| Vitamin D | Active comparator | Drug: CholecalciferolVitamin D Cholecalciferol 2000 IU oral daily for 8 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chronic schizophrenia
- Serum 25(OH)D level below 30 ng/ml
- Deficit in cognitive functions
Key exclusion criteria (4 listed)
- Hypercalcemia
- Hepatic or renal failure
- Obese
- Metabolic syndrome
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 |
|---|---|---|
| Cholecalciferolcholecalciferol 2000 IU oral daily for 8 weeks | Drug | Vitamin D |
| PlaceboOral placebo daily for 8 weeks | Drug | Placebo |
Primary outcome
Cognitive Function
Time frame: At the end of week 8
cognitive function as measured with standard cognitive battery
1 secondary outcome
BDNF serum level
Time frame: At the end of week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cholecalciferol in people with Schizophrenia, run by Universitas Padjadjaran.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuti Kurnianingsih, MD (+62 812 232 9249, kurniatuti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: At the end of week 8). 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 2 Apr 2020.