Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Deficiency, Vitamin D Elderly, Frail Dietary Supplement: Calcifediol 10ug/day Dietary Supplement: Vitamin D3 20ug/day Dietary Supplement: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Calcifediol 10 ug/day
Capsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks.
Dietary Supplement: Calcifediol 10ug/day
Other Name: Hy.D

Experimental: Vitamin D3 20 ug/day
Capsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks.
Dietary Supplement: Vitamin D3 20ug/day
Other Name: Cholecalciferol

Placebo Comparator: Placebo
Capsule without active ingredients, taken together with breakfast for a total period of 24 weeks.
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Change in handgrip strength [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  3. Change in SPPB [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  4. Change in Timed Up and Go test [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  5. Change in Postural Body Sway [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  6. Change in serum Vitamin D3 [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  7. Change in serum 25(OH)D [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  8. Change in serum 1,25(OH)2D3 [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  9. Change in serum 24,25(OH)2D [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  10. Frequency of falling [ Time Frame: baseline, week 12, end of study (after 24 weeks supplementation) ]
  11. Change in muscle fibre type and size (Biopsy) [ Time Frame: baseline, end of study (after 24 weeks supplementation) ]
    Biopsy

  12. Change in body composition (DEXA-scan) [ Time Frame: baseline, end of study (after 24 weeks supplementation) ]
    DEXA-scan

  13. 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

  14. 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

  15. Change in neuromuscular measurements (MUNIX, MUSIX by EMG) [ Time Frame: baseline, end of study (after 24 weeks supplementation) ]
    MUNIX, MUSIX by EMG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349282


Locations
Layout table for location information
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6703HD
Sponsors and Collaborators
Wageningen University
Top Institute Food and Nutrition
DSM Nutritional Products, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02349282     History of Changes
Other Study ID Numbers: NL48127.081.148
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Keywords provided by Wageningen University:
muscle strength
physical performance
vitamin D3
Cholecalciferol
Calcifediol
Additional relevant MeSH terms:
Layout table for MeSH terms
Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents