Clinical trial NCT02349282: The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency, Vitamin D
Elderly, Frail
Keywords: muscle strength
physical performance
vitamin D3
Cholecalciferol
Calcifediol
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
name: DSM Nutritional Products, Inc.
First posted: 2015-01-28
Enrollment: 78
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in muscle strength, knee extension strength (measured by Biodex System)
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
Secondary outcomes:
measure: Change in knee flexion strength (measured by Biodex System)
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in handgrip strength
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in SPPB
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in Timed Up and Go test
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in Postural Body Sway
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in serum Vitamin D3
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in serum 25(OH)D
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in serum 1,25(OH)2D3
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in serum 24,25(OH)2D
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Frequency of falling
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in muscle fibre type and size (Biopsy)
timeFrame: baseline, end of study (after 24 weeks supplementation)
measure: Change in body composition (DEXA-scan)
timeFrame: baseline, end of study (after 24 weeks supplementation)
measure: Change in cognitive functioning (Trail making, Stroop-test, Letter fluency)
timeFrame: baseline, end of study (after 24 weeks supplementation)
measure: Change in vital Signs (blood pressure and heart rate)
timeFrame: baseline, week 12, end of study (after 24 weeks supplementation)
measure: Change in neuromuscular measurements (MUNIX, MUSIX by EMG)
timeFrame: baseline, end of study (after 24 weeks supplementation)
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
References:
citation: 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.
citation: 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.