NCT05211635

Plan D- Vitamin D Supplementation in Psychotic Disorders

Completed NA Last updated 29 January 2025

What this trial tests

NA trial testing Vitamin D in Schizophrenia Spectrum and Other Psychotic Disorders in 14 participants. Completed in 1 January 2025.

Timeline

4 April 2022

Primary endpoint
1 January 2025

1 January 2025

Quick facts

Lead sponsor	University Hospital, Akershus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	14
Start date	4 April 2022
Primary completion	1 January 2025
Estimated completion	1 January 2025
Sites	1 location across Norway

Drugs / interventions tested

• Vitamin D
• Placebo

Conditions studied

• Schizophrenia Spectrum and Other Psychotic Disorders — all drugs for Schizophrenia Spectrum and Other Psychotic Disorders →

Sponsor

University Hospital, Akershus

Who can join

Adults 18 to 65, any sex, with Schizophrenia Spectrum and Other Psychotic Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.