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

Deficiency, Vitamin D Clinical Trial

— D-Fit  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349282
• Other study ID #: NL48127.081.148
• 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

Related Conditions & MeSH terms

• Deficiency, Vitamin D
• Elderly, Frail
• Vitamin D Deficiency

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