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Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia

Phase 3
Conditions
Schizophrenia
Interventions
Registration Number
NCT03284294
Lead Sponsor
Universitas Padjadjaran
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Male
Target Recruitment
40
Inclusion Criteria
  • Chronic schizophrenia
  • Serum 25(OH)D level below 30 ng/ml
  • Deficit in cognitive functions
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Exclusion Criteria
  • Hypercalcemia
  • Hepatic or renal failure
  • Obese
  • Metabolic syndrome
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboOral placebo daily for 8 weeks
Vitamin DCholecalciferolVitamin D Cholecalciferol 2000 IU oral daily for 8 weeks
Primary Outcome Measures
NameTimeMethod
Cognitive FunctionAt the end of week 8

cognitive function as measured with standard cognitive battery

Secondary Outcome Measures
NameTimeMethod
BDNF serum levelAt the end of week 8

BDNF serum level as measured with ELISA method

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