Vitamin D supplements to prevent depression and poor physical function in persons over 60 years

Prevention of depression and poor physical function in older persons with vitamin D supplementation - D-Vitaal

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005332-29-NL

Enrollment

Unknown

Registered

2013-01-09

Start date

2013-01-23

Completion date

Unknown

Last updated

2016-08-08

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

Conditions

depressive symptoms, poor physical functioning.

Interventions

Trade Name: Devaron Product Name: Devaron Product Code: Vitamin D Pharmaceutical Form: Tablet INN or Proposed INN: Colecalciferol CAS Number: 67-97-0 Current Sponsor code: Vitamin D Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age 60-80 years - mild depressive symptoms - at least one functional limitation - serum 25(OH)D levels between 15 and 50 nmol/l (winter) or 15 and 70 nmol/l (summer) - ability to comply with the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 115

Exclusion criteria

Exclusion criteria: - full-blown depressive disorder - use of antidepressants - vitamin D (more than 400 IU/day) or calcium (more than 1000 mg/day) supplementation - major life-threatening illness - living in an aged-people's home or nursing home

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the D-Vitaal trial is to answer the following two questions: 1. Does vitamin D supplementation decrease depressive symptoms in older persons? 2. Does vitamin D supplementation improve physical performance and decrease functional limitations in older persons? ;Secondary Objective: Secondary objectives: investigate whether: - vitamin D supplementation decreases anxiety and improves cognition and quality of life in older persons - vitamin D supplementation prevents the development of full-blown major depression in older persons - vitamin D supplementation is a cost-effective strategy in the prevention of increasing depressive symptoms and functional limitations and declining physical performance.;Primary end point(s): - change in CES-D score (depression questionnaire) - change in physical performance score - change in the number as well as the degree of functional limitations;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The primary objective of the D-Vitaal trial is to answer the following two questions: 1. Does vitamin D supplementation decrease depressive symptoms in older persons? 2. Does vitamin D supplementation improve physical performance and decrease functional limitations in older persons? ;Secondary Objective: Secondary objectives: investigate whether: - vitamin D supplementation decreases anxiety and improves cognition and quality of life in older persons - vitamin D supplementation prevents the development of full-blown major depression in older persons - vitamin D supplementation is a cost-effective strategy in the prevention of increasing depressive symptoms and functional limitations and declining physical performance.;Primary end point(s): - change in CES-D score (depression questionnaire) - change in physical performance score - change in the number as well as the degree of functional limitations;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): - change in anxiety, cogniton and quality of life scores - incidence of full-blown depression - change in timed-up-and-go test score - costs;Timepoint(s) of evaluation of this end point: 6 months, 12 months	—

Countries

Netherlands

Contacts

Public ContactTrial Coordinator

VU University Medical Centre

nm.vanschoor@vumc.nl0031(0)204448439

Outcome results

None listed

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