Plan D- Vitamin D Supplementation in Psychotic Disorders

Summary

Background: Impairment in cognitive processing speed is a consistent finding in schizophrenia spectrum disorder. Vitamin D deficiency is found to be significantly associated with reduced processing speed. In this study, we will investigate the effect from vitamin D supplementation on processing speed.

Objective: The primary objective is to investigate whether vitamin D supplementation is superior to placebo in improving processing speed.

The secondary objectives are to investigate whether vitamin D supplementation is superior to placebo in improving negative symptoms, social and physical activity.

Study design: Randomized placebo-controlled double blind trial. Study population: Men and women, aged 18-65 years, diagnosed with a schizophrenia spectrum disorder, in treatment for their disorder at the Division for Mental Health at Akershus university hospital.

Intervention: Participants will be randomized 1:1 to either vitamin D3 (50µg capsules) or placebo daily for 12 weeks. The medical product or placebo will be given in addition to treatment as usual.

Study measures: Cognitive tests, symptom assessments and blood sampling for vitamin D analyses will be performed at baseline and after 12 weeks intervention. During the 12 week intervention period the participants will use a smart phone application (MinDag) for self-report and an actigraph (MotionWatch 8 actigraph from CamNtech) for registration of physical activity.

Endpoints: Primary outcome is change in cognitive performance on the symbol coding test from the Brief assessment of Cognition in Schizophrenia (BACS). Secondary outcomes are change in performance on the the Category Fluency Test from the MATRICS Consensus Cognitive battery, change in negative symptoms from the clinician rated Brief negative symptom scale (BNSS), and change in self-reported negative symptoms from the scale Self-assessment of negative Negative Symptoms (SNS). Secondary outcomes also include change in self-reported social activities and change in actigraph registered physical activity.

Expected benefits for consumers and caregivers: The results from the study will indicate whether vitamin D supplementation could represent a beneficial treatment strategy for impaired processing speed and related symptoms.

Conditions

• Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

DIETARY_SUPPLEMENT

Vitamin D

One capsule daily for 84 days

OTHER

Placebo

One capsule daily for 84 days

Sponsors & Collaborators

• University of Oslo

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• University Hospital, Akershus

  lead OTHER

Principal Investigators

• Mari Nerhus, PhD · Akershus University Hospital and University of Oslo, NORMENT

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-04

Primary Completion

2025-01-01

Completion

2025-01-01

Countries

• Norway