Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression
D3-vit-dep
Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression
2 other identifiers
interventional
150
1 country
3
Brief Summary
The purpose of this study is to investigate whether patients with depression should be offered vitamin D supplements, or it has no significance in relation to treatment outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 depression
Started Mar 2011
Shorter than P25 for phase_4 depression
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 28, 2012
July 1, 2011
1.2 years
July 5, 2011
March 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton 17 item scale (Hamilton-17)
Change from baseline in Hamilton-17 at week 24
24 weeks
Secondary Outcomes (1)
WHO-Five Well-being Index (WHO-5)
24 weeks
Study Arms (2)
Vitamin D3
ACTIVE COMPARATORone tablet of vitamin D3 (70µg) per day for 24 weeks.
placebo
PLACEBO COMPARATORone tablet of sugar pill per day for 24 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis unipolar depression
You may not qualify if:
- clinical diagnosis sarcoidoses
- tuberculosis
- bipolar affective disorder
- schizophrenia
- hypercalcemia
- hyperphosphatemia
- electroconvulsive treatment for the last 6 months
- primary diagnosis addiction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Mental Health Services Esbjerg
Esbjerg, DK-6715, Denmark
Mental Health Services, Odense
Odense, Dk-5000, Denmark
Mental Health Services Svendborg
Svendborg, DK-5700, Denmark
Related Publications (1)
Hansen JP, Pareek M, Hvolby A, Schmedes A, Toft T, Dahl E, Nielsen CT. Vitamin D3 supplementation and treatment outcomes in patients with depression (D3-vit-dep). BMC Res Notes. 2019 Apr 3;12(1):203. doi: 10.1186/s13104-019-4218-z.
PMID: 30944021DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Connie T Nielsen, PhD
Mental Health Services Esbjerg
- PRINCIPAL INVESTIGATOR
Erik Dahl, MD
Mental Health Services Svendborg
- PRINCIPAL INVESTIGATOR
Tomas toft, PhD
Mental Health Services Odense
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 11, 2011
Study Start
March 1, 2011
Primary Completion
May 1, 2012
Study Completion
December 1, 2012
Last Updated
March 28, 2012
Record last verified: 2011-07