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

Universitas Padjadjaran

Status and phase: Unknown; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Cholecalciferol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03284294

PS-201709.01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Oral placebo daily for 8 weeks

Treatment:

Drug: Placebo

Vitamin D

Active Comparator group

Description:

Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks

Treatment:

Drug: Cholecalciferol