2025-520778-20-00Not yet recruitingPhase 4
EFFECTIVENESS OF SUPPLEMENTATION WITH VITAMIN D IN PATIENTS WITH DEPRESSIVE DISORDER OR BIPOLAR DISORDER: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Evaluation of the effect of cholecalciferol treatment in subjects with depressive disorder or bipolar disorder after 12 weeks.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 28 Jan 2025
- Start date
- 21 Oct 2019
- Lead sponsor
- Azienda Ospedaliera Universitaria Senese
- Diseases
- Bipolar disorder
- EU CT number
- 2025-520778-20-00
- EudraCT number
- 2018-003313-17
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.)
Other illness
- 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
Lab values
- Therapy with calcifediol, calcitriol, cholecalciferol or calcium supplementation in progress or in the previous two months
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Senese | Siena | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.