Schizophrenia
Conditions
Brief 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. 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.
Interventions
DRUGCholecalciferol
cholecalciferol 2000 IU oral daily for 8 weeks
DRUGPlacebo
Oral placebo daily for 8 weeks
Sponsors
Universitas Padjadjaran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Chronic schizophrenia * Serum 25(OH)D level below 30 ng/ml * Deficit in cognitive functions
Exclusion criteria
* Hypercalcemia * Hepatic or renal failure * Obese * Metabolic syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function | At the end of week 8 | cognitive function as measured with standard cognitive battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BDNF serum level | At the end of week 8 | BDNF serum level as measured with ELISA method |
Contacts
Primary ContactTuti Kurnianingsih, MD
Outcome results
None listed