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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24229

Enrollment

140

Registered

2013-02-06

Start date

2013-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

depressive symptoms and poor physical functioning in older persons. depressieve symptomen en matig fysiek functioneren bij ouderen.

Interventions

Experimental group: 1200 IU of vitamin D per day, in 3 tablets of 400 IU, for 12 months. Active substance: Colecalciferol. Product name: Devaron. Placebo group: 3 placebo tablets per day for 12 month

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: 1. Age 60-80 yr; 2. At least one functional limitation; 3. Mild depressive symptoms; 4. Serum 25-hydroxyvitamin D ¡Ý 15 nmol/l and > 50 nmol/l in winter or > 70 nmol/l in summer; 5. Ability to comply with the study.

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: 1. Full-blown depressive disorder; 2. Use of antidepressiva; 3. Serum 25-hydroxyvitamin D 50 nmol/l in winter or > 70 nmol/l in summer; 4. Vitamin D (more than 400 IU/day) or calcium supplementation (more than 1000 mg/day); 5. Major life-threatening illness; 6. Living in an aged people¡¯s home or nursing home.

Design outcomes

Primary

Measure	Time frame
Change in the CES-D score (depressive symptoms), change in physical performance score, and change in the number of functional limitations as well as change in the degree of functional limitations.	—

Secondary

Measure	Time frame
Change in anxiety, cognition, quality of life, incidence of full-blown depression, timed up-and-go-test, and costs.	—

Contacts

Public ContactN.M. Schoor, van

VU University Medical Centre Department of Epidemiology and Biostatistics Van der Boechorststraat 7

nm.vanschoor@vumc.nl+31 (0)20 4448439

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)