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Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression

Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01390662
Acronym
D3-vit-dep
Enrollment
150
Registered
2011-07-11
Start date
2011-03-31
Completion date
2012-12-31
Last updated
2012-03-28

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

Conditions

Depression

Keywords

serum 25-hydroxyvitamin d,vitamin D supplement, depression,, parathyroid hormone

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.

Detailed description

Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun. Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D \[25(OH)D\], which is the storage form of vitamin D in the body, and then in the kidney into the steroid hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D \[1,25(OH)2D\]. At higher latitudes ultraviolet B light is stopped by the atmosphere during winter season. Half of Danes have low levels of \[25(OH)D\] in the blood and especially in the early spring months the levels of \[25(OH)D\] are low. In addition, Vitamin D3 is absorbed through the gut from vitamin D-rich food sources. But several studies show that it is not possible through a recommended diet, which consists of 300 g of fish per week to consume adequate amounts of vitamin D3. New research suggests link between vitamin D3 and brain function.In the Central Nervous System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS. In clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive function, anxiety and depression. The objective of this randomized clinical trial is to investigate whether patients with depression should be offered vitamin D3 supplements, or it has no significance in relation to treatment outcomes. The study is carried out in Mental Health Services in the Region of Southern Denmark for 24 weeks and offered to patients being treated for depression (treatment as usual) plus 70μg vitamin D3 or placebo.

Interventions

DIETARY_SUPPLEMENTVitamin D3

one tablet of vitamin D3 70 µg pr. day, for 24 weeks.

DIETARY_SUPPLEMENTplacebo

one tablet of sugar pill pr. day, for 24 weeks.

Sponsors

Region Syddanmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* clinical diagnosis unipolar depression

Exclusion criteria

* clinical diagnosis sarcoidoses * tuberculosis * bipolar affective disorder * schizophrenia * hypercalcemia * hyperphosphatemia * electroconvulsive treatment for the last 6 months * primary diagnosis addiction

Design outcomes

Primary

MeasureTime frameDescription
Hamilton 17 item scale (Hamilton-17)24 weeksChange from baseline in Hamilton-17 at week 24

Secondary

MeasureTime frameDescription
WHO-Five Well-being Index (WHO-5)24 weeksChange from baseline in WHO-five at week 24

Countries

Denmark

Contacts

Primary ContactConnie T Nielsen, PhD
connie.thuroee.nielsen@psyk.regionsyddanmark.dk+4579182947
Backup ContactAnne-Lene Kjeldmann
anne-lene.kjeldmann@psyk.regionsyddanmark.dk+4579182947

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026