2025-520778-20-00招募中4 期
EFFECTIVENESS OF SUPPLEMENTATION WITH VITAMIN D IN PATIENTS WITH DEPRESSIVE DISORDER OR BIPOLAR DISORDER: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Azienda Ospedaliera Universitaria Senese1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年2月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale - MADRS at 12 weeks of treatment
研究概览
简要总结
Evaluation of the effect of cholecalciferol treatment in subjects with depressive disorder or bipolar disorder after 12 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Subjects referred to the Psychiatry Unit of the Entity at the Azienda Ospedaliera Universitario Senese with a diagnosis of major depressive disorder or disorder bipolar
- •MADRS score >15
- •Serum level of 25(OH) Vitamin D< 20 ng/ml
- •Stable antipsycothic therapy (at least two weeks)
- •Patients able to take Vitamin D supplementation (oral formulation)
- •Willingness to provide free and informed consent.
排除标准
- •Osteoporosis or previous fragility fractures
- •Therapy with calcifediol, calcitriol, cholecalciferol or calcium supplementation in progress or in the previous two months
- •Neoplastic disease or severe liver, kidney or gastrointestinal disease
- •Severe cognitive impairment
- •Acute psychosis
- •Inability to answer questions
- •Refusal to sign informed consent
- •Osteomalacia or Paget's disease
- •Diseases known to have interference with vitamin D metabolism (sarcoidosis, hypercalcemia, renal failure)
- •Pregnancy or lactation
- •Secondary osteoporosis (primary or secondary hyperparathyroidism, hyperprolactinemia, etc.)
- •Therapy with estrogens, drugs for osteoporosis, or drugs known to have interference with bone metabolism (antiepileptics, cortisone, antiretrovirals, heparin etc.)
- •Diabetes mellitus types 1 and 2
- •Lipid metabolism disorders
- •Body Mass Index of less than 18 or more than 34.9 kg/sqm
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale - MADRS at 12 weeks of treatment
Change in Montgomery-Asberg Depression Rating Scale - MADRS at 12 weeks of treatment
Time to remission of depressive disorder (Montgomery-Asberg Depression Rating Scale -MADRS≤ 10)
Time to remission of depressive disorder (Montgomery-Asberg Depression Rating Scale -MADRS≤ 10)
次要结局
- Changes in Montgomery-Asberg Depression Rating Scale (MADRS) score at 24 weeks
- Changes in 25OH vitamin D levels at 12 and 24 weeks
研究者
Clinical Trial Office
Scientific
Azienda Ospedaliera Universitaria Senese
研究点 (1)
Loading locations...
相似试验
尚未招募
4 期
The clinical effect of vitamin D supplementation adjuvant therapy in allergic rhinitisVitamin DAllergic rhinitisTCTR20230426004Department of otorhinolaryngology, Phramongkutklao Hospital46
尚未招募
3 期
effect of vitamin D on the treatment of prostatitisProstatitis.N41.1Chronic prostatitisIRCT20210717051914N1Ahvaz University of Medical Sciences48
招募中
Unknown
The effectiveness of vitamin D supplementation on schizophrenia symptomsSchizophrenia.SchizophreniaIRCT20231109060002N1Yazd University of Medical Sciences72
已完成
1 期
The efficacy of Vitamin D supplementation in the treatment of schizophreniaSchizophrenia.SchizophreniaIRCT201507087373N5Vice chancer for research , Arak University of Medical Sciences70
招募中
2 期
A study of vitamin D supplementation on clinical outcome of COVID-19 infected patients with pneumoniaewly diagnosed COVID-19 pneumonia patients admitted to the hospital for treatmentHigh-dose vitamin D, COVID-19 pneumonia, clinical outcomesTCTR20210906005Faculty of Medicine Ramathibodi Hospital, Mahidol University400