The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population
NCT ID: NCT02349282
Last Updated: 2016-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2014-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Calcifediol 10 ug/day
Capsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks.
Calcifediol 10ug/day
Vitamin D3 20 ug/day
Capsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks.
Vitamin D3 20ug/day
Placebo
Capsule without active ingredients, taken together with breakfast for a total period of 24 weeks.
Placebo
Interventions
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Calcifediol 10ug/day
Vitamin D3 20ug/day
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
Yes
Sponsors
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Top Institute Food and Nutrition
OTHER
DSM Nutritional Products, Inc.
INDUSTRY
Wageningen University
OTHER
Responsible Party
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Locations
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Wageningen University
Wageningen, Gelderland, Netherlands
Countries
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References
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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.
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.
Other Identifiers
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NL48127.081.148
Identifier Type: -
Identifier Source: org_study_id
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