Efficacy of vitamin D supplementation in patients with depressive disorder or bipolar disorder: randomized controlled clinical trial

Phase 1

• Conditions: patients with major depressive disorder or bipolar disorder; MedDRA version: 21.1Level: PTClassification code 10057667Term: Bipolar disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2018-003313-17-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA SENESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-10
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Age between 18 and 75 years
Subjects involved in the psychiatric services of the UOC of Psychiatry of the AOUS both hospitalized in the ordinary or Day Hospital and treated as outpatients with a diagnosis of major depressive disorder or bipolar disorder
MADRS score> 15
Levels of 25 (OH) Vitamin D <20 ng / ml
Patients on antipsychotic therapy should be on a stable dose of medication for at least two weeks
Patients able to take vitamin D supplementation by mouth
Availability to provide their free and informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Patients will not be included in the study if only one of the following exclusion criteria will be present:
Osteoporosis or previous fragility fractures
Osteomalacia or Paget's disease
Known disorders for interference with vitamin D metabolism (sarcoidosis, hypercalcaemia, renal failure)
Pregnancy or breastfeeding
Secondary osteoporosis (primary or secondary hyperparathyroidism, hyperprolactinemia, etc ...)
Taking estrogen, drugs for the treatment of osteoporosis or drugs known to have interference on bone metabolism (antiepileptics, cortisones, antiretrovirals, heparin etc ..)
Type 1 and 2 diabetes mellitus
Lipid metabolism disorders
Body Mass Index lower than 18 or greater than 34.9 kg / sqm
Abuse of narcotic substances
Administration of calcifediol, calcitriol, cholecalciferol or calcium supplementation in progress or in the previous two months
Neoplastic pathologies or severe hepatic, renal or gastrointestinal diseases
Severe cognitive disorder
Acute psychosis
Inability to answer questions
Refusal to sign informed consent

Study & Design

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