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
About this trial
This is an interventional treatment trial for Schizophrenia
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
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
NCT ID
NCT03284294
First Posted
September 4, 2017
Last Updated
March 31, 2020
Sponsor
Universitas Padjadjaran
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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