Plan D- Vitamin D Supplementation in Psychotic Disorders

NCT05211635 | Completed

• 1 other identifier: (REK)-86434
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vitamin D; 25(OH)D; processing speed; digit symbol coding; negative symptoms

Outcome Measures

Primary Outcomes (1)

• Processing speed

  Performance on the symbol coding test from the Brief assessment of Cognition in Schizophrenia (BACS). In this test, the participant is given a printed sheet with a key, linking a number to a nonsense symbol. In the same sheet a row with randomly assigned numbers appears. The participant is then asked to fill out the right corresponding symbol to each number based on the given key, as many as possible within 90 seconds. Measure: number of correct numerals (range: 0-110).

  12 weeks

Secondary Outcomes (5)

• Fluency

  12 weeks

• Negative symptoms

  12 weeks

• Self-reported negative symptoms

  12 weeks

• Social activity

  12 weeks

• Physical activity

  12 weeks

Study Arms (2)

Vitamin D

EXPERIMENTAL

Vitamin D3 capsule 50 µg

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo capsule with identical appearance to the experimental drug

Other: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

One capsule daily for 84 days

Also known as: Divisun 2000 IE

Vitamin D

Placebo OTHER

One capsule daily for 84 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, schizophreniform disorder or psychotic disorder not otherwise specified
• ability to give informed consent
• S-25(OH)D\< 75nmol/L

You may not qualify if:

• psychotic symptoms with organic etiology
• severe mental retardation (IQ\<70)
• hyperparathyroidism
• hypercalcemia
• renal failure (s-creatinine levels above 90µmol/L in women and above 105µmol/L for men)
• pregnancy

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Akershus University Hospital, Division of Psychiatry

Lørenskog, 1478, Norway

Location

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mari Nerhus, PhD

  Akershus University Hospital and University of Oslo, NORMENT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Psychiatry MD PhD

Model Details: Placebo- controlled randomized 1:1 comparison

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: April 4, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)