Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Top Institute Food and Nutrition | OTHER |
| dsm-firmenich Switzerland AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcifediol 10 ug/day | Experimental | Capsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks. |
|
| Vitamin D3 20 ug/day | Experimental | Capsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks. |
|
| Placebo | Placebo Comparator | Capsule without active ingredients, taken together with breakfast for a total period of 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcifediol 10ug/day | Dietary Supplement |
|
| |
| Vitamin D3 20ug/day |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle strength, knee extension strength (measured by Biodex System) | measured by Biodex System | baseline, week 12, end of study (after 24 weeks supplementation) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in knee flexion strength (measured by Biodex System) | measured by Biodex System | baseline, week 12, end of study (after 24 weeks supplementation) |
| Change in handgrip strength | baseline, week 12, end of study (after 24 weeks supplementation) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Medical Illness:
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University | Wageningen | Gelderland | 6703HD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31138136 | Derived | Hangelbroek RWJ, Vaes AMM, Boekschoten MV, Verdijk LB, Hooiveld GJEJ, van Loon LJC, de Groot LCPGM, Kersten S. No effect of 25-hydroxyvitamin D supplementation on the skeletal muscle transcriptome in vitamin D deficient frail older adults. BMC Geriatr. 2019 May 28;19(1):151. doi: 10.1186/s12877-019-1156-5. | |
| 30053278 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002112 | Calcifediol |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D006887 | Hydroxycholecalciferols |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Supplement |
|
|
| Placebo | Dietary Supplement |
|
| Change in SPPB | baseline, week 12, end of study (after 24 weeks supplementation) |
| Change in Timed Up and Go test | baseline, week 12, end of study (after 24 weeks supplementation) |
| Change in Postural Body Sway | baseline, week 12, end of study (after 24 weeks supplementation) |
| Change in serum Vitamin D3 | baseline, week 12, end of study (after 24 weeks supplementation) |
| Change in serum 25(OH)D | baseline, week 12, end of study (after 24 weeks supplementation) |
| Change in serum 1,25(OH)2D3 | baseline, week 12, end of study (after 24 weeks supplementation) |
| Change in serum 24,25(OH)2D | baseline, week 12, end of study (after 24 weeks supplementation) |
| Frequency of falling | baseline, week 12, end of study (after 24 weeks supplementation) |
| Change in muscle fibre type and size (Biopsy) | Biopsy | baseline, end of study (after 24 weeks supplementation) |
| Change in body composition (DEXA-scan) | DEXA-scan | baseline, end of study (after 24 weeks supplementation) |
| Change in cognitive functioning (Trail making, Stroop-test, Letter fluency) | Trail making, Stroop-test, Letter fluency | baseline, end of study (after 24 weeks supplementation) |
| Change in vital Signs (blood pressure and heart rate) | blood pressure and heart rate | baseline, week 12, end of study (after 24 weeks supplementation) |
| Change in neuromuscular measurements (MUNIX, MUSIX by EMG) | MUNIX, MUSIX by EMG | baseline, end of study (after 24 weeks supplementation) |
| Vaes AMM, Tieland M, Toussaint N, Nilwik R, Verdijk LB, van Loon LJC, de Groot LCPGM. Cholecalciferol or 25-Hydroxycholecalciferol Supplementation Does Not Affect Muscle Strength and Physical Performance in Prefrail and Frail Older Adults. J Nutr. 2018 May 1;148(5):712-720. doi: 10.1093/jn/nxy024. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |