EFFECTIVENESS OF SUPPLEMENTATION WITH VITAMIN D IN PATIENTS WITH DEPRESSIVE DISORDER OR BIPOLAR DISORDER: A RANDOMIZED CONTROLLED CLINICAL TRIAL

Not yet recruiting

• Conditions: Depressive disorder; Bipolar disorder

• Registration Number: 2025-520778-20-00
• Lead Sponsor: Azienda Ospedaliera Universitaria Senese

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

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 Criteria

Osteoporosis or previous fragility fractures

Drug abuse

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Changes in Montgomery-Asberg Depression Rating Scale (MADRS) score at 24 weeks		Changes in Montgomery-Asberg Depression Rating Scale (MADRS) score at 24 weeks
Changes in 25OH vitamin D levels at 12 and 24 weeks		Changes in 25OH vitamin D levels at 12 and 24 weeks

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy

Azienda Ospedaliera Universitaria Senese

🇮🇹Siena, Italy

Andrea Fagiolini

Site contact

+390577586273

a.fagiolini@ao-siena.toscana.it