D-Fit: The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Calcifediol 10 ug/day Capsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks. |
Dietary Supplement: Calcifediol 10ug/day
Other Names:
|
| Experimental: Vitamin D3 20 ug/day Capsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks. |
Dietary Supplement: Vitamin D3 20ug/day
Other Names:
|
| Placebo Comparator: Placebo Capsule without active ingredients, taken together with breakfast for a total period of 24 weeks. |
Dietary Supplement: Placebo
|
Outcome Measures
Primary Outcome Measures
- Change in muscle strength, knee extension strength (measured by Biodex System) [baseline, week 12, end of study (after 24 weeks supplementation)]
measured by Biodex System
Secondary Outcome Measures
- Change in knee flexion strength (measured by Biodex System) [baseline, week 12, end of study (after 24 weeks supplementation)]
measured by Biodex System
- Change in handgrip strength [baseline, week 12, end of study (after 24 weeks supplementation)]
- 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) [baseline, end of study (after 24 weeks supplementation)]
Biopsy
- Change in body composition (DEXA-scan) [baseline, end of study (after 24 weeks supplementation)]
DEXA-scan
- Change in cognitive functioning (Trail making, Stroop-test, Letter fluency) [baseline, end of study (after 24 weeks supplementation)]
Trail making, Stroop-test, Letter fluency
- Change in vital Signs (blood pressure and heart rate) [baseline, week 12, end of study (after 24 weeks supplementation)]
blood pressure and heart rate
- Change in neuromuscular measurements (MUNIX, MUSIX by EMG) [baseline, end of study (after 24 weeks supplementation)]
MUNIX, MUSIX by EMG
Eligibility Criteria
Criteria
Inclusion Criteria:
-
25(OH)D levels 20-50 nmol/L.
-
age 65 or older.
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physically frail (pre-frail or frail, based on the criteria designed by Fried et al.) (30). Frailty will be defined as a clinical syndrome in which one or more of the following criteria are present: unintentional weight loss (4.5 kg in past year), self-reported exhaustion (CES-D questionnaire), weakness (grip strength), slow walking speed and low physical activity (Minnesota questionnaire). More details on these criteria are described in chapter 6.3.2.
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body mass index between 18.5 and 35 kg/m2.
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willingness and ability to comply with the protocol, including performance of the knee extension strength test.
Exclusion Criteria:
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Medical Illness:
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malabsorption syndrome: known intestinal malabsorption, celiac diseases, inflammatory bowel disease;
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diseases that may enhance serum calcium concentration: sarcoidosis, lymphoma, kidney stone in the last 10 years, primary hyperparathyroidism;
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abnormal indices of calcium metabolism, uncontrolled hypocalcaemia;
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diagnosed renal insufficiency;
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diagnosed cancer; currently diagnosed or undergoing treatment.
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Hypercalcemia: serum calcium adjusted for albumin of > 2.6 nmol/L.
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Medication: interfering with vitamin D metabolism and vitamin D supplementation (bisphosphonate, PTH treatment, tuberculostatica, anti-epileptica).
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Subject not able (when medically necessary/ advised) or not willing to stop the use of vitamin D containing supplements during the study.
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(Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort) during intervention period.
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Patient heavily consumes alcohol containing products defined as greater than > 21 drinks of alcoholic beverages per week.
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Planned surgery which can affect study measures (taking into account duration of hospitalisation and recovery).
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Participation in another clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wageningen University | Wageningen | Gelderland | Netherlands | 6703HD |
Sponsors and Collaborators
- Wageningen University
- Top Institute Food and Nutrition
- DSM Nutritional Products, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL48127.081.148