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Not yet taking people in ItalyPhase 4

Tests vitamin D in people with depression or bipolar disorder

Tests vitamin D tablets in adults with depression or bipolar disorder over 12 weeks.

Key facts

Who runs it
Azienda Ospedaliera Universitaria Senese
Where
Siena, ItalySee the site
Registry title
EFFECTIVENESS OF SUPPLEMENTATION WITH VITAMIN D IN PATIENTS WITH DEPRESSIVE DISORDER OR BIPOLAR DISORDER: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Status
Not yet recruiting
Phase
Phase 4
People taking part
150 people, planned
Started
21 Oct 2019
Planned end
31 Oct 2025
Type of study
Interventional
Record updated
10 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with major depressive disorder or bipolar disorder who have a low vitamin D level. It tests vitamin D (cholecalciferol) treatment over 12 weeks.

Age
18-75 years
Sex
All sexes can join.
Disease stage
Diagnosis of major depressive disorder or bipolar disorder, referred to the Psychiatry Unit of the Azienda Ospedaliera Universitario Senese, with a MADRS score above 15.
Earlier treatment
Stable antipsychotic therapy for at least two weeks. No calcifediol, calcitriol, cholecalciferol or calcium supplements now or in the previous two months.
Biomarker or test result
Blood level of 25(OH) Vitamin D below 20 ng/ml.

Main reasons for not taking part

  • Osteoporosis or earlier fragility fractures
  • Drug abuse
  • Cancer, or severe liver, kidney or gut disease
  • Diabetes type 1 or type 2
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

  • Azienda Ospedaliera Universitaria SeneseSiena, ItalyNot yet recruiting

About the trial

What the trial wants to find out

Evaluation of the effect of cholecalciferol treatment in subjects with depressive disorder or bipolar disorder after 12 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
EFFECTIVENESS OF SUPPLEMENTATION WITH VITAMIN D IN PATIENTS WITH DEPRESSIVE DISORDER OR BIPOLAR DISORDER: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Plain-language title
Tests vitamin D in people with depression or bipolar disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
10 February 2025