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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02349282
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : January 11, 2016
Sponsor:
Collaborators:
Top Institute Food and Nutrition
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Wageningen University

Tracking Information
First Submitted Date  ICMJE December 22, 2014
First Posted Date  ICMJE January 28, 2015
Last Update Posted Date January 11, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
Change in muscle strength, knee extension strength (measured by Biodex System) [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
measured by Biodex System
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
  • Change in knee flexion strength (measured by Biodex System) [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
    measured by Biodex System
  • Change in handgrip strength [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  • Change in SPPB [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  • Change in Timed Up and Go test [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  • Change in Postural Body Sway [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  • Change in serum Vitamin D3 [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  • Change in serum 25(OH)D [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  • Change in serum 1,25(OH)2D3 [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  • Change in serum 24,25(OH)2D [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  • Frequency of falling [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  • Change in muscle fibre type and size (Biopsy) [ Time Frame: baseline, end of study (after 24 weeks supplementation) ]
    Biopsy
  • Change in body composition (DEXA-scan) [ Time Frame: baseline, end of study (after 24 weeks supplementation) ]
    DEXA-scan
  • Change in cognitive functioning (Trail making, Stroop-test, Letter fluency) [ Time Frame: baseline, end of study (after 24 weeks supplementation) ]
    Trail making, Stroop-test, Letter fluency
  • Change in vital Signs (blood pressure and heart rate) [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
    blood pressure and heart rate
  • Change in neuromuscular measurements (MUNIX, MUSIX by EMG) [ Time Frame: baseline, end of study (after 24 weeks supplementation) ]
    MUNIX, MUSIX by EMG
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Deficiency, Vitamin D
  • Elderly, Frail
Intervention  ICMJE
  • Dietary Supplement: Calcifediol 10ug/day
    Other Name: Hy.D
  • Dietary Supplement: Vitamin D3 20ug/day
    Other Name: Cholecalciferol
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Experimental: Calcifediol 10 ug/day
    Capsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks.
    Intervention: Dietary Supplement: Calcifediol 10ug/day
  • Experimental: Vitamin D3 20 ug/day
    Capsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks.
    Intervention: Dietary Supplement: Vitamin D3 20ug/day
  • Placebo Comparator: Placebo
    Capsule without active ingredients, taken together with breakfast for a total period of 24 weeks.
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2015)
78
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02349282
Other Study ID Numbers  ICMJE NL48127.081.148
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wageningen University
Study Sponsor  ICMJE Wageningen University
Collaborators  ICMJE
  • Top Institute Food and Nutrition
  • DSM Nutritional Products, Inc.
Investigators  ICMJE Not Provided
PRS Account Wageningen University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP