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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02349282
Other study ID # NL48127.081.148
Secondary ID
Status Completed
Phase N/A
First received December 22, 2014
Last updated January 8, 2016
Start date December 2014
Est. completion date December 2015

Study information

Verified date January 2016
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Dietary Supplement:
Calcifediol 10ug/day

Vitamin D3 20ug/day

Placebo


Locations

Country Name City State
Netherlands Wageningen University Wageningen Gelderland

Sponsors (3)

Lead Sponsor Collaborator
Wageningen University DSM Nutritional Products, Inc., Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

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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