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. Secondary objectives are to assess the change in serum 25(…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
verminderd fysiek functioneren, vitamine D deficientie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in muscle strength within 24 weeks, the primary outcome measure is
knee extension strength test.
Secondary outcome
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.
Background 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 in maintaining or
improving physical functioning, particularly in vulnerable populations, results
are contradicting. Randomized, placebo-controlled trials are needed to further
establish the effect of vitamin D in the frail elderly population. Besides
supplementation with vitamin D3, one treatment-arm will be supplemented with
Calcifediol. Calcifediol is considered to be 2 to 3 times more potent in
increasing 25(OH)D concentration up to an optimal level compared to vitamin D3.
Therefore, supplementation with the active metabolite may have benefits
superior to vitamin D3 on improving muscle strength and performance. 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.
Study objective
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. Secondary objectives 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, Short
Physical Performance Battery (SPPB) and TUG test, postural body sway, blood
pressure, cognitive functioning and neuromuscular functioning.
Study design
The study will be a randomised, double-blind, placebo-controlled, intervention
trial, with 3 treatment arms.
Intervention
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, supplementations of 10 µg/day Calcifediol
(Hy.D 25 SD/S), 20 µg/day vitamin D3 or placebo for an intervention period of
24 weeks.
Study burden and risks
The risks involved in participating in this study are minimal. The doses used
in this study have shown to be safe in previous trials. Muscle biopsies will be
performed by an experienced physician and will heal completely. There is a
small risk of infection and the muscle biopsy can lead to minor hematoma. The
risk of the blood collection is merely that of a small local hematoma, feeling
light-headed, fainting or an infection. The physical performance tests and
strength measurements might result in feelings of muscle soreness. EMG
measurements are completely safe. Skin preparation along with placement of the
electrodes might result in a skin rash, but generally subsides in a few days.
Electrical stimulation can result in the perception of discomfort during the
stimulus. To minimize the discomfort, stimuli will be very short in duration
(only 100 microseconds in length). For elderly, the social aspect can be an
important reason to participate and therefore, study visits will be carried out
in small groups. In addition, the subjects will receive a final report of their
own results of the performed tests (if it so wishes).
Bomenweg 4
Wageningen 6703 HD
NL
Bomenweg 4
Wageningen 6703 HD
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48127.081.14 |