NCT01462058

Brief Summary

The purpose of this study is to investigate whether vitamin D3 (70 micrograms) is better than placebo in preventing depression symptoms among employees in health care

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 29, 2012

Status Verified

March 1, 2012

Enrollment Period

5 months

First QC Date

October 26, 2011

Last Update Submit

March 28, 2012

Conditions

Seasonal Affective DisorderVitamin D3Mental HealthDietary Supplement

Keywords

SPAQSigh-SADHamilton 29Vitamin D3p25(OH)D

Outcome Measures

Primary Outcomes (1)

  • Hamilton-29

    Change from baseline in Hamilton-29 at week 12

    12 weeks

Secondary Outcomes (1)

  • WHO-5

    12 weeks

Study Arms (2)

Vitamin D3

ACTIVE COMPARATOR

one tablet of vitamin D3 (70µg) per day for 12 weeks.

Dietary Supplement: Vitamin D3

placebo

PLACEBO COMPARATOR

one tablet of sugar pill per day for 12 weeks.

Drug: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT

70µg Vitamin D3, daily, 12 weeks

Also known as: Active
Vitamin D3
PlaceboDRUG

Placebo, daily, 12 weeks

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health service staff and employee in the Region of Southern Denmark.
  • Tendency to depressive symptoms in the winter season SPAQ\>7.

You may not qualify if:

  • clinical diagnosis sarcoidoses
  • tuberculosis
  • bipolar affective disorder
  • schizophrenia
  • hypercalcemia
  • hyperphosphatemia
  • pregnancy
  • hyperparathyroidism
  • reduced kidney function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Services Esbjerg

Esbjerg, Esbjerg N, 6715, Denmark

Location

Related Publications (1)

  • Frandsen TB, Pareek M, Hansen JP, Nielsen CT. Vitamin D supplementation for treatment of seasonal affective symptoms in healthcare professionals: a double-blind randomised placebo-controlled trial. BMC Res Notes. 2014 Aug 14;7:528. doi: 10.1186/1756-0500-7-528.

    PMID: 25125215DERIVED

MeSH Terms

Conditions

Seasonal Affective DisorderPsychological Well-Being

Interventions

CholecalciferolExercise

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, ph.d

Study Record Dates

First Submitted

October 26, 2011

First Posted

October 28, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 29, 2012

Record last verified: 2012-03

Locations

DK(1)