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

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
Universitas Padjadjaran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Vitamin D

    Arm Description

    Oral placebo daily for 8 weeks

    Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks

    Outcomes

    Primary Outcome Measures

    Cognitive Function
    cognitive function as measured with standard cognitive battery

    Secondary Outcome Measures

    BDNF serum level
    BDNF serum level as measured with ELISA method

    Full Information

    First Posted
    September 4, 2017
    Last Updated
    March 31, 2020
    Sponsor
    Universitas Padjadjaran
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03284294
    Brief Title
    Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia
    Official Title
    The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 15, 2020 (Anticipated)
    Primary Completion Date
    August 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitas Padjadjaran

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Controlled Trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Oral placebo daily for 8 weeks
    Arm Title
    Vitamin D
    Arm Type
    Active Comparator
    Arm Description
    Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Cholecalciferol
    Intervention Description
    cholecalciferol 2000 IU oral daily for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Oral placebo daily for 8 weeks
    Primary Outcome Measure Information:
    Title
    Cognitive Function
    Description
    cognitive function as measured with standard cognitive battery
    Time Frame
    At the end of week 8
    Secondary Outcome Measure Information:
    Title
    BDNF serum level
    Description
    BDNF serum level as measured with ELISA method
    Time Frame
    At the end of week 8

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tuti Kurnianingsih, MD
    Phone
    +62 812 232 9249
    Email
    kurniatuti@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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