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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Dietary supplement: Vitamin D3; Dietary supplement: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark, DK-6715
    • Recruiting
    • Mental Health Services Esbjerg
    • Contact: Connie T Nielsen, PhD; Phone Number: +4579182947; Email: connie.thuroee.nielsen@psyk.regionsyddanmark.dk
    • Principal Investigator: Connie T Nielsen, PhD
  • Odense, Denmark, Dk-5000
    • Recruiting
    • Mental Health Services, Odense
    • Contact: Tomas Toft, Ph.D; Phone Number: +4565413300; Email: tomas.toft@psyk.regionsyddanmark.dk
    • Principal Investigator: Tomas Toft, PhD
  • Svendborg, Denmark, DK-5700
    • Recruiting
    • Mental Health Services Svendborg
    • Contact: Erik Dahl, MD; Phone Number: 63201051; Email: Erik.dahl@psyk.regionsyddanmark.dk
    • Principal Investigator: Erik Dahl, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin D3; one tablet of vitamin D3 (70µg) per day for 24 weeks.	Dietary supplement: Vitamin D3; one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
Placebo Comparator: placebo; one tablet of sugar pill per day for 24 weeks.	Dietary supplement: placebo; one tablet of sugar pill pr. day, for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton 17 item scale (Hamilton-17)	Change from baseline in Hamilton-17 at week 24	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WHO-Five Well-being Index (WHO-5)	Change from baseline in WHO-five at week 24	24 weeks

Collaborators and Investigators

• Sponsor: Region Syddanmark
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): May 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Estimate): March 28, 2012
• Last Update Submitted That Met QC Criteria: March 27, 2012
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: parathyroid hormone; serum 25-hydroxyvitamin d,vitamin D supplement, depression,
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 26992; 2010-023531-42 (EudraCT Number)