Deficiency, Vitamin D Clinical Trial
— D-FitOfficial title:
The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population: a Randomized, Double-blind, Placebo-controlled Trial.
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - 25(OH)D levels 20-50 nmol/L. - age 65 or older. - 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. - body mass index between 18.5 and 35 kg/m2. - willingness and ability to comply with the protocol, including performance of the knee extension strength test. 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 the 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). - 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University | Wageningen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University | DSM Nutritional Products, Inc., Top Institute Food and Nutrition |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | Change in knee flexion strength (measured by Biodex System) | measured by Biodex System | baseline, week 12, end of study (after 24 weeks supplementation) | No |
Secondary | Change in handgrip strength | baseline, week 12, end of study (after 24 weeks supplementation) | No | |
Secondary | Change in SPPB | baseline, week 12, end of study (after 24 weeks supplementation) | No | |
Secondary | Change in Timed Up and Go test | baseline, week 12, end of study (after 24 weeks supplementation) | No | |
Secondary | Change in Postural Body Sway | baseline, week 12, end of study (after 24 weeks supplementation) | No | |
Secondary | Change in serum Vitamin D3 | baseline, week 12, end of study (after 24 weeks supplementation) | No | |
Secondary | Change in serum 25(OH)D | baseline, week 12, end of study (after 24 weeks supplementation) | No | |
Secondary | Change in serum 1,25(OH)2D3 | baseline, week 12, end of study (after 24 weeks supplementation) | No | |
Secondary | Change in serum 24,25(OH)2D | baseline, week 12, end of study (after 24 weeks supplementation) | No | |
Secondary | Frequency of falling | baseline, week 12, end of study (after 24 weeks supplementation) | No | |
Secondary | Change in muscle fibre type and size (Biopsy) | Biopsy | baseline, end of study (after 24 weeks supplementation) | No |
Secondary | Change in body composition (DEXA-scan) | DEXA-scan | baseline, end of study (after 24 weeks supplementation) | No |
Secondary | Change in cognitive functioning (Trail making, Stroop-test, Letter fluency) | Trail making, Stroop-test, Letter fluency | baseline, end of study (after 24 weeks supplementation) | No |
Secondary | Change in vital Signs (blood pressure and heart rate) | blood pressure and heart rate | baseline, week 12, end of study (after 24 weeks supplementation) | No |
Secondary | Change in neuromuscular measurements (MUNIX, MUSIX by EMG) | MUNIX, MUSIX by EMG | baseline, end of study (after 24 weeks supplementation) | No |
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