search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number14334
- NTR NumberNTR3845
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-feb-2013
- Secondary IDs2012/354 / 2012/041 / NL41567.029.12; METC VUmc / Wetenschapscommissie EMGO+ Instituut VUmc / CCMO
- Public TitleVitamin D supplements to prevent depression and poor physical function in persons over 60 years.
- Scientific TitlePrevention of depression and poor physical function in older persons with vitamin D supplementation.
- ACRONYMD-Vitaal
- hypothesisDepressive symptoms are common in older persons, often associated with poor physical function and vitamin D deficiency (serum 25-hydroxyvitamin D < 50 nmol/l). Simple and cheap interventions to prevent depression are lacking. Vitamin D deficiency occurs in 50% of persons >65 yr and has been associated with an increase in depressive symptoms in many studies, as well as with functional limitations and declining physical performance. A prior randomized placebo-controlled trial on the effect of vitamin D supplementation in overweight persons showed a decrease in depressive symptoms. Vitamin D supplementation also had a positive influence on mobility tests in several clinical trials. A mechanistic explanation is available: the vitamin D receptor is present in muscle cells as well as in brain tissue, especially in the hypothalamus. The hypothesis is that vitamin D decreases depressive symptoms and improves physical performance and functional limitations in older persons. Secondary hypotheses are that vitamin D decreases anxiety, improves quality of life and prevents the development of full-blown depression in older persons.
- Healt Condition(s) or Problem(s) studiedOlder adults, Depressive symptoms, Physical functioning
- Inclusion criteriaIn 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 ≥ 15 nmol/l and > 50 nmol/l in winter or > 70 nmol/l in summer;
5. Ability to comply with the study.
- Exclusion criteriaA 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 < 15 nmol/l and 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2013
- planned closingdate1-mrt-2015
- Target number of participants140
- InterventionsExperimental 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 months. (similar to Devaron tablets in size, shape, taste etc., but no active substance).
- Primary outcomeChange 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 outcomeChange in anxiety, cognition, quality of life, incidence of full-blown depression, timed up-and-go-test, and costs.
- TimepointsPrimary outcomes:
1. Change in depressive symptoms (CES-D score) after 12 months;
2. Change in physical performance score after 12 months;
3. Change in number and degree of functional limitations after 12 months.

Secondary outcomes:
1. Change in depressive symptoms (CES-D score), after 6 months;
2. Change in physical performance score after 6 months;
3. Change in number and degree of functional limitations after 6 months;
4. Number of subjects with a full-blown major depressive disorder (CIDI score) after 6 and 12 months;
5. Change in anxiety (Beck Anxiety Index score) after 6 and 12 months;
6. Change in cognition (Stroop Colour-Word Test score) after 6 and 12 months;
7. Change in quality of life (EQ-5D and SF-36 score) after 6 and 12 months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. N.M. Schoor, van
- CONTACT for SCIENTIFIC QUERIESDr. N.M. Schoor, van
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground of the study:
Depressive symptoms are common in older persons, often associated with poor physical function and vitamin D deficiency (serum 25-hydroxyvitamin D < 50 nmol/l). Simple and cheap interventions to prevent depression are lacking. Vitamin D deficiency occurs in 50% of persons >65 yr and has been associated with an increase in depressive symptoms in many studies, as well as with functional limitations and declining physical performance. A prior randomized placebo-controlled trial on the effect of vitamin D supplementation in overweight persons showed a decrease in depressive symptoms. Vitamin D supplementation also had a positive influence on mobility tests in several clinical trials. A mechanistic explanation is available: the vitamin D receptor is present in muscle cells as well as in brain tissue, especially in the hypothalamus. The hypothesis is that vitamin D decreases depressive symptoms and improves physical performance and functional limitations in older persons. Secondary hypotheses are that vitamin D decreases anxiety, improves cognitive functioning and quality of life, and prevents the development of full-blown depression in older persons.

Objective of the study:
Primary objectives:
1. Does vitamin D supplementation improve depressive symptoms in older persons?
2. Does vitamin D supplementation improve physical performance and functional limitations in older persons?

Secondary objectives:
1. Does vitamin D supplementation decrease anxiety and improve cognitive function and quality of life in older persons?
2. Can vitamin D supplementation prevent the development of full-blown depression in older persons?
3. Is vitamin D supplementation a cost-effective strategy in the prevention of increasing depressive symptoms and functional limitations and declining physical performance?

Study design:
A randomized double-blind placebo-controlled intervention study on the effect of vitamin D 1200 IU per day versus placebo on depressive symptoms, physical performance and functional limitations. The duration of intervention and follow-up is one year.

Study population:
Potential participants are recruited in The Netherlands, aged 60 to 80 years, are recruited in general practices with the Center of Epidemiological Studies Depression Scale (CES-D). They are eligible when having mild depressive symptoms, i.e. a CES-D score of 16 or higher. Further inclusion criteria are the presence of at least one functional limitation and a serum 25-hydroxyvitamine D concentration between 15 nmol/l and 50 nmol/l in winter or 70 nmol/l in summer. Patients with a diagnosis of depression are excluded. According to the sample size calculation and drop out, 50 persons per group, i.e.100 persons are required. Because of uncertainty in the 25-hydroxyvitamin D assay during screening, 70 persons per group will be included, altogether 140 persons..

Intervention:
The patients are randomized into two groups: vitamin D 1200 IU (three tablets of 400 IU per day) or placebo (three tablets per day) for one year.

Primary study parameters/outcome of the study:
Change in the CES-D score, change in physical performance score after 12 months, change in the number of functional limitations as well as change of degree of functional limitations.

Secundary study parameters/outcome of the study:
Change in anxiety, cognition, quality of life, incidence of full-blown depression, timed up-and-go-test, costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Potential participants are screened with postal questionnaires and a screening visit to their general practice (short questionnaire and blood sample). After screening, they have to come 3 times to the general practice or health center at baseline, after 6 and 12 months. They have to complete questionnaires, perform physical performance tests, and a blood sample is drawn twice at baseline and 6 months. Assessments at 3 weeks, 3 months and 9 months are by telephone. The risk of the vitamin D treatment is negligible.
- Main changes (audit trail)
- RECORD6-feb-2013 - 16-feb-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl