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

Efficacy of vitamin D supplementation in patients with depressive disorder or bipolar disorder: randomized controlled clinical trial - VIT_D_2018

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003313-17-IT

Enrollment

150

Registered

2021-02-10

Start date

2019-05-08

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with major depressive disorder or bipolar disorder MedDRA version: 21.1 Level: PT Classification code 10057667 Term: Bipolar disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: DIBASE - "50.000 U.I./2,5 ML SOLUZIONE ORALE" 1 CONTENITORE MONODOSE DA 2,5 ML Product Name: DIBASE Product Code: [DIBASE] Pharmaceutical Form: Oral drops, solution INN or Proposed INN: CO

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the effect of treatment with cholecalciferol in subjects with depressive disorder or bipolar disorder after 12 weeks.;Secondary Objective: Evaluation of the effect of treatment with cholecalciferol in subjects with depressive disorder or bipolar dysplasia after 24 weeks. Evaluation of vitamin D status at 12 and 24 weeks.;Primary end point(s): Change in Montgomery-Asberg Depression Rating Scale -MADRS at 12 weeks of treatment time of remission of depressive disorder (Montgomery-Asberg Depression Rating Scale -MADRS= 10);Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: Evaluation of the effect of treatment with cholecalciferol in subjects with depressive disorder or bipolar disorder after 12 weeks.;Secondary Objective: Evaluation of the effect of treatment with cholecalciferol in subjects with depressive disorder or bipolar dysplasia after 24 weeks. Evaluation of vitamin D status at 12 and 24 weeks.;Primary end point(s): Change in Montgomery-Asberg Depression Rating Scale -MADRS at 12 weeks of treatment time of remission of depressive disorder (Montgomery-Asberg Depression Rating Scale -MADRS= 10);Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): secondary: Variations of the Montgomery-Asberg Depression Rating Scale (MADRS) score of 24 weeks Changes in vitamin D 25OH levels at 12 and 24 weeks. exploratory Change in IL-6 and TNF-alpha levels at 12 and 24 weeks;Timepoint(s) of evaluation of this end point: 12 and 24 months	—

Countries

Italy

Contacts

Public ContactUOC Medicina Interna 1

Azienda Ospedaliera Universitaria Senese

ranuccio.nuti@unisi.it0577586450

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026