Influence of Vitamin D Supplementation on Serum BDNF Leve... | NCT03284294

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

NCT03284294

Sponsor

Universitas Padjadjaran

Status

Unknown status

Last Update Posted

Apr 2, 2020Actual

Enrollment

40Estimated

Phase

Phase 3

Conditions

Schizophrenia

Interventions

Cholecalciferol
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2020Estimated

Primary Completion Date

Aug 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Sep 4, 2017

First Submission Date that Met QC Criteria

Sep 14, 2017

First Posted Date

Sep 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2020

Last Update Posted Date

Apr 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tuti Kurnianingsih, Principal Investigator, Universitas PadjadjaranPrincipal Investigator

Lead Sponsor

Universitas PadjadjaranOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Oral placebo daily for 8 weeks	Drug: Placebo
Vitamin D	Active Comparator	Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks	Drug: Cholecalciferol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Drug	cholecalciferol 2000 IU oral daily for 8 weeks	Vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive Function	cognitive function as measured with standard cognitive battery	At the end of week 8

Secondary Outcomes

Measure	Description	Time Frame
BDNF serum level	BDNF serum level as measured with ELISA method	At the end of week 8

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tuti Kurnianingsih, MD	Contact	+62 812 232 9249		kurniatuti@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided