The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population

Not Applicable

Completed

• Conditions: Deficiency, Vitamin D; Elderly, Frail
• Interventions: Dietary Supplement: Vitamin D3 20ug/day; Dietary Supplement: Placebo; Dietary Supplement: Calcifediol 10ug/day

• Registration Number: NCT02349282
• Lead Sponsor: Wageningen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 20 ug/day	Vitamin D3 20ug/day	Capsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks.
Placebo	Placebo	Capsule without active ingredients, taken together with breakfast for a total period of 24 weeks.
Calcifediol 10 ug/day	Calcifediol 10ug/day	Capsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change in muscle strength, knee extension strength (measured by Biodex System)	baseline, week 12, end of study (after 24 weeks supplementation)	measured by Biodex System

Secondary Outcome Measures

Name	Time	Method
Change in SPPB	baseline, week 12, end of study (after 24 weeks supplementation)
Change in serum 25(OH)D	baseline, week 12, end of study (after 24 weeks supplementation)
Change in serum 24,25(OH)2D	baseline, week 12, end of study (after 24 weeks supplementation)
Change in vital Signs (blood pressure and heart rate)	baseline, week 12, end of study (after 24 weeks supplementation)	blood pressure and heart rate
Change in Timed Up and Go test	baseline, week 12, end of study (after 24 weeks supplementation)
Change in Postural Body Sway	baseline, week 12, end of study (after 24 weeks supplementation)
Change in serum 1,25(OH)2D3	baseline, week 12, end of study (after 24 weeks supplementation)
Change in knee flexion strength (measured by Biodex System)	baseline, week 12, end of study (after 24 weeks supplementation)	measured by Biodex System
Change in serum Vitamin D3	baseline, week 12, end of study (after 24 weeks supplementation)
Change in handgrip strength	baseline, week 12, end of study (after 24 weeks supplementation)
Frequency of falling	baseline, week 12, end of study (after 24 weeks supplementation)
Change in muscle fibre type and size (Biopsy)	baseline, end of study (after 24 weeks supplementation)	Biopsy
Change in body composition (DEXA-scan)	baseline, end of study (after 24 weeks supplementation)	DEXA-scan
Change in cognitive functioning (Trail making, Stroop-test, Letter fluency)	baseline, end of study (after 24 weeks supplementation)	Trail making, Stroop-test, Letter fluency
Change in neuromuscular measurements (MUNIX, MUSIX by EMG)	baseline, end of study (after 24 weeks supplementation)	MUNIX, MUSIX by EMG

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Gelderland, Netherlands