EFFECTIVENESS OF SUPPLEMENTATION WITH VITAMIN D IN PATIENTS WITH DEPRESSIVE DISORDER OR BIPOLAR DISORDER: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Key facts
- Where
- Siena, OlaszországSee the site
- Phase
- 4. fázis
Where in Olaszország
- Azienda Ospedaliera Universitaria SeneseSiena, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliera Universitaria Senese
- Trial code
- EU 2025-520778-20-00
- Record updated
- 2025. február 10.
- Original description
Evaluation of the effect of cholecalciferol treatment in subjects with depressive disorder or bipolar disorder after 12 weeks.Read full original descriptionShow less
Evaluation of the effect of cholecalciferol treatment in subjects with depressive disorder or bipolar disorder after 12 weeks.
Inclusion: 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.
Exclusion: Osteoporosis or previous fragility fractures; Drug abuse; Therapy with estrogens, drugs for osteoporosis, or drugs known to have interference with bone metabolism (antiepileptics, cortisone, antiretrovirals, heparin etc.); Neoplastic disease or severe liver, kidney or gastrointestinal disease; Severe cognitive impairment; Osteomalacia or Paget's disease; Diseases known to have interference with vitamin D metabolism (sarcoidosis, hypercalcemia, renal failure); Diabetes mellitus types 1 and 2; Lipid metabolism disorders; Therapy with calcifediol, calcitriol, cholecalciferol or calcium supplementation in progress or in the previous two months; Acute psychosis; Inability to answer questions; Refusal to sign informed consent; Pregnancy or lactation; Secondary osteoporosis (primary or secondary hyperparathyroidism, hyperprolactinemia, etc.); Body Mass Index of less than 18 or more than 34.9 kg/sqm.