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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)

Primary Purpose

Deficiency, Vitamin D, Elderly, Frail

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Calcifediol 10ug/day
Vitamin D3 20ug/day
Placebo
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deficiency, Vitamin D focused on measuring muscle strength, physical performance, vitamin D3, Cholecalciferol, Calcifediol

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wageningen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Calcifediol 10 ug/day

Vitamin D3 20 ug/day

Placebo

Arm Description

Capsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks.

Capsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks.

Capsule without active ingredients, taken together with breakfast for a total period of 24 weeks.

Outcomes

Primary Outcome Measures

Change in muscle strength, knee extension strength (measured by Biodex System)
measured by Biodex System

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2014
Last Updated
January 8, 2016
Sponsor
Wageningen University
Collaborators
Top Institute Food and Nutrition, DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02349282
Brief Title
The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
Collaborators
Top Institute Food and Nutrition, DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deficiency, Vitamin D, Elderly, Frail
Keywords
muscle strength, physical performance, vitamin D3, Cholecalciferol, Calcifediol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcifediol 10 ug/day
Arm Type
Experimental
Arm Description
Capsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks.
Arm Title
Vitamin D3 20 ug/day
Arm Type
Experimental
Arm Description
Capsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsule without active ingredients, taken together with breakfast for a total period of 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcifediol 10ug/day
Other Intervention Name(s)
Hy.D
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 20ug/day
Other Intervention Name(s)
Cholecalciferol
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in muscle strength, knee extension strength (measured by Biodex System)
Description
measured by Biodex System
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Secondary Outcome Measure Information:
Title
Change in knee flexion strength (measured by Biodex System)
Description
measured by Biodex System
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in handgrip strength
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in SPPB
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in Timed Up and Go test
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in Postural Body Sway
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in serum Vitamin D3
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in serum 25(OH)D
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in serum 1,25(OH)2D3
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in serum 24,25(OH)2D
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Frequency of falling
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in muscle fibre type and size (Biopsy)
Description
Biopsy
Time Frame
baseline, end of study (after 24 weeks supplementation)
Title
Change in body composition (DEXA-scan)
Description
DEXA-scan
Time Frame
baseline, end of study (after 24 weeks supplementation)
Title
Change in cognitive functioning (Trail making, Stroop-test, Letter fluency)
Description
Trail making, Stroop-test, Letter fluency
Time Frame
baseline, end of study (after 24 weeks supplementation)
Title
Change in vital Signs (blood pressure and heart rate)
Description
blood pressure and heart rate
Time Frame
baseline, week 12, end of study (after 24 weeks supplementation)
Title
Change in neuromuscular measurements (MUNIX, MUSIX by EMG)
Description
MUNIX, MUSIX by EMG
Time Frame
baseline, end of study (after 24 weeks supplementation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Wageningen University
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6703HD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31138136
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.
Results Reference
derived
PubMed Identifier
30053278
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.
Results Reference
derived

Learn more about this trial

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

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