verminderd fysiek functioneren, vitamine D deficientie impaired physical performance vitamin D deficiency
Conditions
Interventions
Subjects will be randomly allocated to one of the three intervention groups,
stratified by gender and BMI (18.5-29.9, 30-35 kg/m2). The three groups will
receive, in a double blinded way, supplement
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 25(OH)D levels 20-50 nmol/L. - age 65 or older. - male or female gender. - physically pre-frail or frail - body mass index between 18.5 and 35 kg/m2. - willingness and ability to comply with the protocol, including performance of the knee extension strenght test.
Exclusion criteria
Exclusion criteria: - Medical illness: malabsorption syndrome (known intestinal malabsorption, celiac diseases, inflammatory bowel disease), diseases that may enhance serum calcium concentration (sarcoidosis, lymphoma, kidney stone in last 10 years, primary hyperparathyroidism), abnormal indices of calcium metabolism, uncontrolled hypocalcaemia, diagnosed renal insufficiency, diagnosed cancer (currently diagnosed or undergoing treatment) - Hypercalcemia: serum calcium adjusted for albumin of > 2.6 nmol/L. - Medication: interfering with vitamin D metabolism and vitamin D supplementation; bisphosphonate, PTH treatment, tuberculostatica, anti-epileptica, bile acid sequestrate (Colestyramine, Colestipol) and lipase inhibitors (Orlistat). - Subject not able (when medically necessary/ advised) or not willing to stop the use of vitamin D containing supplements during the study. - (Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort) during intervention period. - Patient heavily consumes alcohol containing products defined as greater than > 21 drinks of alcoholic beverages per week. - Planned surgery which can affect study measures (taking into account duration of hospitalisation and recovery). - Participation in another clinical trial. - Subjects taking anticoagulation medication (with an exception of platelet inhibitors like aspirin) will be included in the study, but excluded from the muscle biopsy procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in muscle strength within 24 weeks, the primary outcome measure is knee extension strength test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are to assess the change in serum 25(OH)D level, frequency of falling, muscle fibre type and size, muscle mass and body composition, handgrip strength, SPPB, TUG, postural body sway, blood pressure, cognitive functioning and neuromuscular functioning. | — |
Countries
Netherlands
Outcome results
None listed