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

NCT ID: NCT03284294

Last Updated: 2020-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Oral placebo daily for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral placebo daily for 8 weeks

Vitamin D

Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

cholecalciferol 2000 IU oral daily for 8 weeks

Interventions

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Cholecalciferol

cholecalciferol 2000 IU oral daily for 8 weeks

Intervention Type DRUG

Placebo

Oral placebo daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universitas Padjadjaran

OTHER

Sponsor Role lead

Responsible Party

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Tuti Kurnianingsih

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tuti Kurnianingsih, MD

Role: CONTACT

+62 812 232 9249

Other Identifiers

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PS-201709.01

Identifier Type: -

Identifier Source: org_study_id

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