Vitamin D supplementation to prevent depression and poor physical function in older adults: Study protocol of the D-Vitaal study, a randomized placebo-controlled clinical trial

Abstract

BackgroundDepressive symptoms and decreased physical functioning are interrelated conditions and common in older persons, causing significant individual and societal burden. Evidence suggests that vitamin D supplementation may be beneficial for both mental and physical functioning. However, previous randomized controlled trials have yielded inconsistent results and often had suboptimal designs. This study examines the effect of vitamin D supplementation on both depressive symptoms and physical functioning in a high-risk population of older persons with low vitamin D status.Methods/designThe D-Vitaal study is a randomized, double-blind, placebo-controlled trial investigating the effects of a daily dose of 1200 IU vitamin D3 versus placebo for one year on depressive symptoms and physical functioning (primary outcomes) in older adults. Participants (N = 155, age 60–80 years) were recruited from the general population. Eligibility criteria included the presence of depressive symptoms, ≥1 functional limitation and serum 25-hydroxyvitamin D levels between 15 and 50/70 nmol/L (depending on season). Secondary outcomes include incidence of major depressive disorder, anxiety symptoms, health-related quality of life, cognitive function and cost-effectiveness of the intervention.DiscussionWith this study, we aim to elucidate the effects of vitamin D supplementation on depressive symptoms and physical functioning in older persons who are at high risk of developing more substantial mental and physical problems. If effective, vitamin D supplementation can be a preventive intervention strategy that is easy to implement in the primary care setting.Trial registrationNetherlands Trial Register NTR3845. Registered 6 February 2013.

Vitamin D Supplementation Improves Mood in Women with Type 2 Diabetes

“…The D-Vitaal study is an RCT being conducted in the Netherlands which include 155 adults, aged 60 and older, who have significant depressive symptoms and low vitamin D levels. They are examining the impact of daily vitamin D 3 (1200 IU) versus placebo taken for one year on depressive symptoms and physical functioning [ 54 ]. In the United States, the VITAL-DEP will examine the impact of daily supplements (2000 IU D 3 , 840 mg omega-3 fatty acids, both, or placebo) taken for five years in preventing the onset of late-life depression (using PHQ-9) [ 55 ].…”

Vitamin D and Physical Function in Sedentary Older Men

“…Ongoing clinical trials worldwide will further contribute to answering this important clinical question. The Prevention of Depression and Poor Physical Function in Older Persons with Vitamin D Supplementation being conducted in the Netherlands will assess the effectiveness of supplementation with cholecalciferol 1,200 IU daily for 12 months to prevent depression and decline in physical function as assessed using the SPPB, Timed Up and Go test, and handgrip test in 140 men and women aged 60 to 80 with baseline 25(OH)D less than 20 ng/mL in winter and less than 28 ng/mL in summer . It is expected that participants will reach 25(OH)D levels of greater than 32 ng/mL.…”

“…The Prevention of Depression and Poor Physical Function in Older Persons with Vitamin D Supplementation being conducted in the Netherlands will assess the effectiveness of supplementation with cholecalciferol 1,200 IU daily for 12 months to prevent depression and decline in physical function as assessed using the SPPB, Timed Up and Go test, and handgrip test in 140 men and women aged 60 to 80 with baseline 25(OH)D less than 20 ng/mL in winter and less than 28 ng/mL in summer. 51 It is expected that participants will reach 25 (OH)D levels of greater than 32 ng/mL. The Vitamin D Assessment Study in New Zealand has enrolled community-dwelling adults who will receive cholecalciferol 100,000 IU monthly for an estimated median of 3.3 years; a subset of participants will be tested for muscle strength, gait, and balance.…”

The Relationship Between Serum 25-Hydroxyvitamin D Levels and Physical Performance in Community-Dwelling Older Adults

“…Scores of 0-3, 4-6, 7-9, and 10-12 are classified as severe, moderate, mild, and minimal lower extremity limitations, respectively. 26)…”