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NCT03284294 Clinical Trial

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

Schizophrenia Clinical Trial

Official title:
The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03284294
Other study ID # PS-201709.01
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date April 15, 2020
Est. completion date December 2020

Study information
Verified date March 2020
Source Universitas Padjadjaran
Contact Tuti Kurnianingsih, MD
Phone +62 812 232 9249
Email kurniatuti@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date December 2020
Est. primary completion date August 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cholecalciferol
cholecalciferol 2000 IU oral daily for 8 weeks
• Placebo
Oral placebo daily for 8 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitas Padjadjaran

Outcome
Type Measure Description Time frame Safety issue
Primary Cognitive Function cognitive function as measured with standard cognitive battery At the end of week 8
Secondary BDNF serum level BDNF serum level as measured with ELISA method At the end of week 8
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