Plan D- a Randomized Controlled Trial of Vitamin D Supplementation in Psychotic Disorders Including the Use of Digital Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Processing speed
研究概览
简要总结
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.
详细描述
Background:
Vitamin D deficiency is considered a risk factor for schizophrenia spectrum disorders. The influence from vitamin D may be specifically important in the developing fetal brain. However, vitamin D deficiency is also found to be associated with symptom severity in established schizophrenia spectrum disorder, indicating that vitamin D also plays an important role in the adult brain. Our research group has found a strong association between low vitamin D levels and higher symptom burden of depressive- and negative symptoms, and associations between vitamin D deficiency and cognitive impairments, reduced processing speed in particular. Our results are in line with results from other studies. Symptoms of vitamin D deficiency per se involves motor fatigue and muscle weakness, and vitamin D is found to be crucial for the connectivity in neuronal circuits responsible for both locomotor-, emotional- and reward dependent behavior. Despite the strong associations between vitamin D deficiency and core features of schizophrenia spectrum disorders, very few intervention studies have been performed in schizophrenia samples.
The cognitive impairment of reduced processing speed is evaluated by standardized cognitive tests. The task could be to match symbols and letters by writing on a sheet of paper, to draw a pattern or solve a puzzle. The ability to perform will thus be dependent on the actual physical speed, the interaction between brain activity and body movements, i.e. psychomotor function, and cognition. In this study we will therefore investigate vitamin D's effect om cognitive processing speed and the effects on other outcomes related to psychomotor function. We will use both well-known clinical methods as well as new digital measures to measure potential effects.
Sociodemographic and diagnostic assessments:
Age, sex, cultural background, education level, work-, and civil status will be mapped by a structured interview and by information obtained from patient records. The Structured Clinical Interview for DSM-5 Disorders, Clinician Version (SCID-5 CV) will be used for diagnostic purposes. Current medication will be registered by interview or obtained from patient records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Processing speed
时间窗: 12 weeks
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).
次要结局
- Social activity(12 weeks)
- Fluency(12 weeks)
- Negative symptoms(12 weeks)
- Self-reported negative symptoms(12 weeks)
- Physical activity(12 weeks)
研究者
Mari Nerhus
Consultant in Psychiatry MD PhD
University Hospital, Akershus