In an ageing population, the need for interventions to help older people remain healthy, active and independent for as long as possible, increases. Although several studies suggest a beneficial effect of vitamin D3 on maintaining or improving muscle strength and physical functioning, particularly in vulnerable populations, results are contradicting. Randomized, placebo-controlled trials are needed to further establish the effect of vitamin D on muscle strength in the frail elderly population.The primary aim of this study is to determine the effect of daily supplementation with two different forms of vitamin D on muscle strength in frail elderly people over a period of 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
Wageningen University
Wageningen, Gelderland, Netherlands
Change in muscle strength, knee extension strength (measured by Biodex System)
measured by Biodex System
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in knee flexion strength (measured by Biodex System)
measured by Biodex System
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in handgrip strength
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in SPPB
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in Timed Up and Go test
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in Postural Body Sway
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in serum Vitamin D3
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in serum 25(OH)D
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in serum 1,25(OH)2D3
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in serum 24,25(OH)2D
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Frequency of falling
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in muscle fibre type and size (Biopsy)
Biopsy
Time frame: baseline, end of study (after 24 weeks supplementation)
Change in body composition (DEXA-scan)
DEXA-scan
Time frame: baseline, end of study (after 24 weeks supplementation)
Change in cognitive functioning (Trail making, Stroop-test, Letter fluency)
Trail making, Stroop-test, Letter fluency
Time frame: baseline, end of study (after 24 weeks supplementation)
Change in vital Signs (blood pressure and heart rate)
blood pressure and heart rate
Time frame: baseline, week 12, end of study (after 24 weeks supplementation)
Change in neuromuscular measurements (MUNIX, MUSIX by EMG)
MUNIX, MUSIX by EMG
Time frame: baseline, end of study (after 24 weeks supplementation)
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